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Medical Devices

Updated: September 22, 2020 12:00 AM

September 22, 2020 12:00 AM

“Company name: Becton, Dickinson and Company
Brand name: Alaris
Product recalled: BD Alaris System Hardware
Reason of the recall: Potential for four hardware situations that may result in the infusion pump not operating as expected
FDA Recall date: September 21, 2020
Recall details: Three Recall... See Mores Designated as Class I by FDA; One Designated as Class II BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on  previously announced voluntary recalls of the BD Alaris™ System. Three of the recalls, which BD announced on Aug. 4, 2020, have been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means that FDA has determined that there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.

One of the situations was designated as a Class II recall, which means use of the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. This FDA classification does not change the guidance BD provided in the company’s Aug. 4th recall announcements to customers. BD initiated the voluntary recalls to notify customers of the potential for four hardware situations that may result in the infusion pump not operating as expected. BD has provided instructions to correct and/or mitigate the situations.

The four recalls include:  Alaris PC Unit Model 8015 Front Case with Keypad Replacement Kits(Recall 1 – Class I):
The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress, potentially resulting in a delay to the start of infusion, interruption of infusion or inability to titrate medication.

Alaris Pump Module Model 8100 Front Case with Keypad Replacement Kits(Recall 2 – Class I):
Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress, potentially resulting in a delay to the start of infusion or interruption of infusion.

BD Alaris™ Syringe Module Model 8110 and PCA Module Model 8120(Recall 3 - Class I):
The Alaris PC unit may display incorrect syringe type and/or syringe sizes. This could potentially result in delays in infusion, under-infusion or over-infusion.

BD Alaris™ EtCO2 Module model 8300 channel error(Recall 4 – Class II)
Infusion pump component defect may result in interruption of patient monitoring.

Customers should review and follow the instructions in each of the recall letters listed above. Affected Products:

- Recall 1:  BD Alaris™ PC Unit model 8015 (manufactured from April 7, 2017 to present)
PC Unit Front Case with Keypad Replacement Kits:
TC10008389  ASSY CASE FRONT W/KEYPAD 8015LS
TC10010217  ASSY FRT CASE W/ KEYPAD 8015 M2
TC10012515  ASSY FR CASE W/ KEYPAD 8015 M2
TC10013702  ASSY, CASE, FRONT W/KEYPAD, 8015LS
TC10013664  ASSY FR CASE W/ KEYPAD 8015 M2

- Recall 2:  BD Alaris™ Pump Module Model 8100 (manufactured from December 1, 2016 to January 23, 2019)
Pump Module Door Assembly Replacement Kits (labeled with a date prior to January 25, 2019)
Affected part numbers: 49000239; 49000346; 49000438; 49000439

- Recall 3: BD Alaris™ Syringe Module Model 8110 (manufactured from March 1, 2010 to present)
BD Alaris™ PCA Module Model 8120 (manufactured from March 1, 2010 to present)
Syringe/PCA Sizer Sensor Replacement Kit (manufactured from March 1, 2010 to present)
Affected part number: 12278652 

- Recall 4: Alaris™ EtCO2 Module, Model 8300 (manufactured from January 5, 2018 to January 4, 2019)

Note that some affected devices may be branded under the CareFusion name. Customer inquiries related to this action should be addressed to BD’s Recall Support Center at 888-562-6018 or SupportCenter@bd.com. FDA MedWatch Reporting Adverse reactions/events experienced with the use of either of these products should also be reported to the FDA's MedWatch Program.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 1, 2020 5:05 PM

“Company name: Becton, Dickinson and Company
Brand name: Alaris
Product recalled: Alaris Infusion Pump
Reason of the recall: Hardware issues may cause the infusion pump to not operate as expected
FDA Recall date: September 01, 2020
Recall details: Majority of June 30 Recall Designated as Class I... See MoreRecall by FDA
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on a previously announced voluntary recall of the BD Alaris™ System.

Three of the situations described in this recall, which BD announced on June 30, 2020, have been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means that there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. One of the situations was designated as a Class II recall, which means use of the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

This FDA classification does not change the guidance BD provided in the company's June recall announcement to customers.

BD initiated the voluntary recall to notify customers of the potential for four hardware situations that may result in the infusion pump not operating as expected. BD has provided instructions to correct and/or mitigate the situations. The four situations include:
- Damaged Inter-Unit Interface (IUI) Connectors (Situation 1 – Class I)
- Broken elements on Alaris™ Pump Module platen (Situation 2 – Class I)
- Improperly secured PC unit Battery (Situation 3 – Class I)
- Dim LED Segment(s) on the Alaris™ modules (Situation 4 – Class II)

Customers should review and follow the instructions in the recall letter: www.bd.com/en-us/support/recall-notifications/recall-notification-for-alaris-system-infusion-pump-hardware

Check the list of affected Products on the link below. Note that some affected devices may be branded under the CareFusion name. Customer inquiries related to this action should be addressed to BD's Recall Support Center at 888-562-6018 or SupportCenter@bd.com.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 8, 2020 5:00 PM

“Company name: Endologix® Inc.
Brand name: Ovation
Product recalled: Ovation iX system
Reason of the recall: A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer.
FDA Recall date: July 08, 2020
Recall details: Company Announcem... See Moreent Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that a correction notice has been issued for the Ovation iX system, that identifies the root cause of polymer leaks. This voluntary action has been classified by the FDA as a Class 1 recall. No physical product removal of the product is planned or needed. Correction Z-2263-2020 was issued in May 2020 to current users of the Ovation iX system and informs users of a material weakness adjacent to the polymer fill channel that may become compromised during pressurization with liquid polymer. The clinical sequelae associated with polymer leaks may be systemic or aneurysm related. All lots/serial numbers, not yet implanted, of the following models are in the scope of the correction:
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User

July 8, 2020 4:00 PM

“Company name: CME America
Brand name: BodyGuard
Product recalled: Infusion System Administration Set (infusion set)
Reason of the recall: Use of the pump system potentially could cause over-infusion or under-infusion of therapy
FDA Recall date: July 08, 2020
Recall details: PRNewswire/ - CME Am... See Moreerica, a wholly owned subsidiary of BD (Becton, Dickinson and Company), announced a voluntary recall for all CME America BodyGuard® Infusion System Administration Sets (infusion sets) used with the company's BodyGuard® infusion pumps—that were distributed beginning May 2016 (see complete impacted product list below).  This action was initiated on June 16, 2020. As part of CME America's commitment to quality, following the previously announced recall (April 27, 2020) of the BodyGuard® Infusion Pump Systems, the company conducted additional flow-rate accuracy testing.

This testing revealed that some infusion sets do not meet the ±5% delivery accuracy for the system or the ±13% accuracy identified in the earlier recall notification (bd.com Therefore, the use of the pump system potentially could cause over-infusion or under-infusion of therapy and patient harm. Based on those test results CME America is providing additional information and customer actions regarding its previous recall to include all infusion sets used with the BodyGuard® infusion pump distributed beginning May 2016.

CME America has defined four categories of impacted infusion sets based on delivery inaccuracy variability, two of which (Category A and B) can continue to be used in accordance with the instructions in the recall letter (bd.com CME America also announced on April 27, 2020, the decision to suspend distribution of the BodyGuard® infusion pumps and to remove all existing products from the U.S. market. CME America will work with customers to address the latest expanded infusion set recall and will continue to maintain continuity of care during the COVID-19 pandemic. Until such time that the BodyGuard® pumps have been removed from the market, CMEA will supply accessories and infusion sets in "Category A" and "Category B" to support the infusion pumps, and customers can continue to use the products in accordance with the Operator's Manual and the additional mitigations outlined in the customer letter.

Affected Product Types:

- BodyGuard BodySet
- BodyGuard Microset with Needleless Adaptor
- BodyGuard Microsets
- BodyGuard Microset w/ Non-Vented Spike Connector
- BodyGuard set with Female Luer
- BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer
- BodyGuard Microsets with Filter
- Standard BodySet with Needleless Connectors
- BodyGuard Microset with Filter and Manual Priming Valve
- CMExpress Microbore Sets
- BodyGuard Microset with Male Luer Connectors
- CMExpress Needleless Y Site Microbore Set

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

June 24, 2020 6:00 PM

“Company name: Chengdu Ai Qin E-commerce Co., Ltd
Brand name: TTDeye
Product recalled: Colored contact lenses
Reason of the recall: Distributed without FDA clearance may pose health risk
FDA Recall date: June 24, 2020
Recall details: On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiate... See Mored a nationwide recall of 1362 pairs of colored contact lenses. The relevant series of contact lenses have been found to be distributed without FDA clearance and may pose a threat to health. The company has received no complaints to date.

These colored contact lenses were sold through the company website and shipped directly to the customer from 08/05/2019 - 10/11/2019. The recalled products were manufactured in August 2018 and may be identified by name of the product and the date of manufacture, “2018-08”, found on the package label. The following products are being recalled:

- TTDeye. Black Starshine. Lot code: B16112100
- TTDeye. Diamonds Starlight. Lot code: B16112203
- TTDeye. Flower. Lot code: Brown. Lot code: B16112210
- TTDeye. Flower Grey. Lot code: B16112231
- TTDeye. Radial. Lot code: Brown. Lot code: B16112109
- TTDeye. Radial Pink. Lot code: B16112110
- TTDeye. Devil Red. Lot code: B16112201

If you have received this product, immediately cease use and contact the company via online chat at www.ttdeye.com between 9AM and 6PM (GMT+8) or contact the company via email at info@ttdeye.com (24 hours) for further information.

Chengdu Ai Qin E-commerce Co., Ltd is notifying its customers by email and is arranging for return/replacement of all recalled colored contact lenses.

Chengdu Ai Qin E-commerce Co., Ltd is voluntarily recalling these contact lenses after becoming aware of the problem. Chengdu Ai Qin E-commerce Co., Ltd has notified the FDA of this action.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

June 1, 2020 11:00 PM

“Company name: Allergan Aesthetics
Brand name: BIOCELL
Product recalled: Breast Implants
Reason of the recall: Increased risk of BIA-ALCL
FDA Recall date: June 01, 2020
Recall details: Allergan Aesthetics, an AbbVie company (NYSE: ABBV), is initiating a new digital campaign to improve device tra... See Morecking and further identify and reach breast implant patients who have, or have had, BIOCELL® breast implants and/or tissue expanders to inform them of the risk of BIA-ALCL. Since July 2019 when the BIOCELL® recall was announced, robust efforts were made to reach patients, however, the Company is still seeking to directly contact all U.S. BIOCELL® patients that have not yet been notified. This is due to incomplete device tracking data for approximately 52,000 BIOCELL® breast implant units.

It is important to note the United States Food and Drug Administration (FDA) has made the following recommendation, "If you have no symptoms, we are not recommending the removal of these or other types of breast implants due to the low risk of developing BIA-ALCL. However, if you have any questions, talk to your health care provider."

Allergan Aesthetics will launch a multi-channel campaign which will include digital and social media advertisements further informing patients of the voluntary recall and directing them to Allergan Aesthetics' www.BIOCELLinformation.com website for education on how to identify their implant type and register their implants.

"Allergan Aesthetics is committed to patient safety and we are continuing to make every effort to make sure that each and every patient is made aware of the BIOCELL® recall, and knows their implant type and implant history," said John Maltman, Vice President of Medical Affairs at Allergan Aesthetics.

If patients are not aware of the BIOCELL® recall previously announced on July 24, 2019, and do not know the type of implant that they have in place or their implant history, they should either:
- Go to www.BIOCELLinformation.com to reach out to Allergan Aesthetics to determine if the company has their implant information.
- Contact their surgeon or hospital where they received implants to determine if the surgeon or hospital has records of their implant information.

Patients who know that they have an Allergan implant, and may not have participated in device tracking previously, or who need to update their information on www.BIOCELLinformation.com. The website will inform them how to register for device tracking, which is strongly advised for all patients, and answer any questions they may have. Patients with BIOCELL® implants or tissue expanders or a history of BIOCELL® implants or tissue expanders should go to www.BIOCELLinformation.com to learn about the BIOCELL® recall, symptoms of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), the importance of breast self-examination and the need for regular breast implant monitoring.

"We are determined to make sure every woman has the information they need related to the BIOCELL® voluntary recall and we will continue to encourage women with breast implants to determine their implant type and opt-in to our device tracking system. Patient education is a priority. We have partnered with the American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS) on major initiatives to raise awareness regarding the importance of breast implant tracking," said Carrie Strom, Senior Vice President AbbVie and President Global Allergan Aesthetics.

About the GLOBAL BIOCELL® Recall On July 24, 2019 Allergan initiated a voluntary global recall of its BIOCELL® breast implants and tissue expanders. Allergan has continued a global basis to ensure that patients and health care professions are notified about the BIOCELL® recall. The Company issued global press releases and distributed letters directly to healthcare professionals regarding the recall.

To generate awareness and provide a resource for patients, the Company launched a dedicated website, www.BI- OCELLinformation.com, to help patients identify their breast implants and to provide information and resources related to the risk of BIA-ALCL.

Allergan Aesthetics, an AbbVie company will continue to work closely with global regulatory authorities and societies and patient advocacy groups to provide important BIOCELL® information to patients and health care professionals regarding the voluntary recall.

More information on BIA-ALCL: BIA-ALCL is not breast cancer—it is a type of non-Hodgkin's lymphoma (cancer of the immune system). At this time, the likelihood of developing BIA-ALCL is thought to be low, occurring in less than 0.03% of patients with BIOCELL® textured breast implants. However, BIA-ALCL is a serious condition and
can lead to death, especially if not diagnosed early or treated promptly.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

April 29, 2020 7:00 PM

“Company name: CME America
Brand name: CMEAmerica BodyGuard
Product recalled: Infusion pumps and infusion sets
Reason of the recall: pumps may not deliver fluid at the accuracy specified in the instructions for use and infusion sets may under-deliver fluids
FDA Recall date: April 29, 2020
Recall... See Moredetails: CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of CMEAmerica BodyGuard® infusion pumps (FDA Recall Number: Z-1474-2020) and the other related to one of the device's infusion sets (FDA Recall Number: Z-1442-2020). Both previously announced recalls have now been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means the FDA believes that there is a reasonable probability that use of the recalled product(s) will cause serious adverse health consequences or death.

CME America previously notified customers affected by each recall and provided guidance on the potential impact to device performance when the affected products were used. Today, the company has issued an updated customer letter with additional guidance and to inform customers of the decision to suspend distribution of the BodyGuard® infusion pump system and to remove all existing products from the U.S. market.

The following is a summary of each individual product recall details:

CMEAmerica BodyGuard® Infusion Pump Recall

Details On Jan. 6, 2020, the company initiated a voluntary recall to notify customers of certain scenarios where pumps may not deliver fluid at the accuracy specified in the instructions for use that could result in a slower than expected delivery of medication (under-infusion), and/or faster than expected delivery of medication (over-infusion). Results indicate that pumps may have a delivery inaccuracy of up to ~13%. To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America has assessed the potential risks associated with the issues outlined in the initial voluntary recall and determined that the BodyGuard® infusion pump may continue to be used in certain situations in accordance with the Operator's Manual and the additional mitigations outlined in the updated customer letter until the pumps have been removed from the market.

To ensure customers retain access to critical medical equipment, particularly as the COVID-19 pandemic continues to evolve in the United States, CME America will implement a phased market removal and will continue to support the following activities in order to help limit clinical disruption and maintain patient focus during the COVID-19 pandemic: Use of products in the field in accordance with the Operator's Manual and the additional mitigations outlined in the updated customer letter; Product service and repair activities at CME America and Authorized Service Depots; and Supply of infusion sets and accessories to support the infusion pumps remaining in the field.

The BodyGuard® infusion pump is designed to deliver fluids or medications into a patient's body in controlled amounts. The pump administers fluids through an infusion tubing set into a patient's vein or through other cleared routes of administration. The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments. Typical applications for the BodyGuard® infusion pumps include but are not limited to chemotherapy, pain management, TPN, enteral nutrition fluids and antibiotics.

The recall and market removal affect approximately 28,400 devices, including all models of BodyGuard® infusion pumps listed below. These devices are primarily used in outpatient settings.
- BodyGuard 121
- BodyGuard 323
- BodyGuard 545*
- BodyGuard 575*
- BodyGuard 545 ColorVision
- BodyGuard 575 ColorVision
- CMExpress

*Note: These two pump models were inadvertently left out of the initial customer notification

CMEAmerica BodyGuard® Microset Infusion Set Recall

Details On Sept. 16, 2019, the company initiated a voluntary recall to notify customers that certain lots of BodyGuard® Microset infusion sets, when used with the BodyGuard® infusion pump, may under-deliver fluids up to 50% at the highest flow rates. At the time of the recall, CME America informed customers in the recall announcement to discard all remaining inventory of the infusion sets (Catalog #A120-003XYVA) and committed to reimbursing impacted customers. To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America immediately stopped shipments of the affected infusion sets. This FDA classification does not change the previous guidance provided in the company's September recall announcement to customers. Affected products include:

CMEAmerica BodyGuard® Microset, Catalog #A120-003XYVA.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

April 21, 2020 2:00 PM

“Company name: Trividia Health, Inc.
Brand name: TRUE METRIX
Product recalled: TRUE METRIX® AIR Blood Glucose Meter
Reason of the recall: Incorrect factory-set unit of measure
FDA Recall date: April 21, 2020
Recall details: Trividia Health, Inc. today announced it is initiating a nationwide vol... See Moreuntary recall of one (1) TRUE METRIX® AIR Blood Glucose Meter distributed in the United States to one customer (AssuraMed). The meter was not packaged into storebrand or retail branded packaging. The company has determined that one (1) isolated TRUE METRIX AIR Blood Glucose Meter was packaged into a TRUE METRIX Blood Glucose Meter kit and has an incorrect factory-set unit of measure; the meter displays glucose results in mmol/L rather than mg/dL. If a consumer does not notice the incorrect unit of measure, it is possible that the meter glucose result will be read as a lower blood glucose result than expected, and this may result in the patient’s glucose level remaining high, which can lead to serious injury or impairment with risk of death.

There is one (1) affected TRUE METRIX AIR meter with serial number TA1548753 that was packaged into a TRUE METRIX Blood Glucose Meter Kit with the Lot number KW0135 and with UDI # (01)00021292006075(17)200831(10)KW0135(21)TA1548753. It has been determined that this kit was distributed nationwide in the United States in February 2019. Trividia Health has not received any reports of patient injury or an adverse event related to this voluntary recall.

If you have the affected TRUE METRIX AIR meter, please stop using the meter and call Trividia Health immediately to verify the serial number, and to expedite return and replacement of the affected TRUE METRIX AIR meter at no charge.

Consumers may continue to test blood glucose using any other Trividia Health blood glucose meter not included in this voluntary recall while waiting for their replacement meter to arrive. Use only the test strips that are intended for use with your blood glucose meter.
Notifications will be sent to US pharmacies, durable medical equipment providers and distributors who may have received this device from Trividia’s customer. Patient safety is a top priority at Trividia Health.

The company has notified the U.S. Food and Drug Administration (FDA) of this voluntary product recall and is working with the customer who received the affected meter to quickly resolve this matter. Users within the USA may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online or by phone.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

April 3, 2020 2:01 PM

“Company name: Becton, Dickinson, and Company
Brand name: BD Alaris
Product recalled: BD Alaris System PC Units and Modules
Reason of the recall: Infusion pump may not operate as expected
FDA Recall date: March 10, 2020
Recall details: BD (Becton, Dickinson and Company), a leading global medical... See Moretechnology company, today provided an update on a previously announced voluntary recall of the BD Alaris™ System regarding software for the PC Unit and certain modules. BD has notified customers affected by this recall, and there is no change to those recall instructions.This recall, which BD announced on Feb. 4, 2020, has been designated as a Class I recall by the U.S. Food and Drug Administration (FDA) and has been associated with medical device reporting (MDR) submissions. This FDA classification does not change the guidance BD provided in the company’s February recall announcement to customers.BD initiated the voluntary recall to notify customers of five issues where the infusion pump may not operate as expected and provide corrections and mitigations to protect patient safety. The five items include: Software errors related to System Error Code 255-XX-XXX;
Delay options programming;
Low Battery Alarm Failure;
Keep vein open (KVO)/End of Infusion alarms priority;
Use errors related to Customer Concentrations Programming.
Customers should review and follow the instructions in the recall letter:bd.com/alaris-system-software-recall.As previously communicated, BD is committed to seeking clearance of a comprehensive 510(k) filing for the Alaris™ System, which will remediate the issues identified in the Feb. 4, 2020 recall notification.In the interim, BD is providing important user actions in the recall notification letter to help mitigate the potential risks until these software issues are fully remediated. BD has also created a dedicated team of clinical consultants to support training for health care providers. For more information and to review all of the available resources provided by BD, please visit: bd.com/alaris-system-software-recall.Affected ProductsBD Alaris™ System PC Unit Model 8000, software versions 9.5 and prior
BD Alaris™ System PC Unit Model 8015, software versions 12.1.0 and prior
BD Alaris™ Pump Module Model 8100, software versions 12.1.0 and prior
Alaris™ Syringe Module Model 8110, software versions 12.1.0 and prior
Alaris™ PCA Module Model 8120, software versions 12.1.0 and prior
Note that some affected devices may be branded under the CareFusion name.
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User

April 3, 2020 2:01 PM

“Company name: Advanced Bionics
Brand name: HiRes Ultra and Ultra 3D
Product recalled: Cochlear implants
Reason of the recall: Reports of hearing performance degradation
FDA Recall date: March 10, 2020
Recall details: Advanced Bionics (AB), a global leader in developing advanced cochlear implant... See Moresystems, announced today that it has begun notifying regulatory authorities that it will voluntarily initiate a field corrective action related to the initial version of HiRes Ultra and Ultra 30 cochlear implant devices due to a decrease in performance experienced by a small percentage of recipients.AB's priority is to ensure that all cochlear implant recipients and health care providers have the information they need to understand this situation and that they receive the necessary support. Existing recipients of HiRes Ultra and Ultra 3D may continue to use their device as normal. If recipients experience issues of hearing degradation they should visit their audiologist or other health care provider. In addition, we will begin the notification process for device recipients worldwide, where allowed, to make them aware of the potential issue. This voluntary action is being taken in an abundance of caution in response to recent increases in Ultra device explants related to low impedances and reports of hearing performance degradation. As of February 11, 2020, of the more than 16,000 recipients of these implants, less than 0.5% have been explanted for this reason. Please note that this device-related issue may manifest in performance degradation that could require revision surgery. The only potential for patient harm are the risks associated with a surgery. AB has identified factors that contribute to the clinical symptoms leading to explant and hearing performance degradation. This information will be provided to health care professionals and recipients in geographies that allow. As of February 11th, in the small number of cases that have been explanted, fluid ingress at the electrode has occurred leading to interruption of stimulation. The hermetic seal of the implant case has been shown to be intact. In our efforts to continually improve our products and in response to early reports of this issue AB has developed several improvements to the device to address the issue (new version). AB has received regulatory approval from the FDA in the US and TUV SUD in Europe for these improvements. AB is in the process of submitting these improvements to additional global regulatory agencies. AB plans to distribute products in these geographies as soon as approvals are obtained. AB will continue to distribute the HiRes 90K Advantage cochlear implant as well as the new version of HiRes Ultra and Ultra 3D based on market availability.Previous generations of AB cochlear implants and external sound processors and accessories are not included in the scope of this voluntary field action. AB's primary concern is the safety and hearing performance of our recipients as well as the reliability of our products. AB continues to take all necessary corrective and preventative efforts to address this unforeseen occurrence.
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User

Recent Interesting Reports

September 23, 2020 3:00 PM

“Company name: Sun Pharmaceutical Industries
Brand name: Riomet ER
Product recalled: Metformin Hydrochloride for Extended-Release Oral Suspension
Reason of the recall: Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
FDA Recall date: September 23, 2020
Recall details: Sun Pharmace... See Moreutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level.  The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake (ADI) limit established by the U.S. Food and Drug Administration. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. 

NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.  To date, SUN PHARMA has not received any reports of adverse events related to this recall.  RIOMET ER™ (metformin hydrochloride for extended-release oral suspension) is a prescription oral medication indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.  RIOMET ER™, when reconstituted, is packaged in a 16 oz. (473 mL) round bottle.  Each carton contains one bottle of drug pellets, one bottle of diluent, and one dosing cup.  The affected RIOMET ER™ is the following lot:

- RIOMET ER™ (metformin hydrochloride for extended-release oral suspension) 500 mg per 5 mL. Lot # AB06381. NDC #10631-019-17. Expiration Date: 10/2021. Number of Units: 747 cartons.

The product can be identified by the bottles or carton labeled as RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), containing the specific Lot Number and Expiration Date referenced above or on the labeling below. The product was distributed nationwide to wholesale customers.

SUN PHARMA is notifying its distributors and customers through its third-party Recall Coordinator (Inmar Inc.), via FedEx standard overnight shipping and will arrange for return of all recalled products.

Distributors and retailers that have RIOMET ER™ (metformin hydrochloride for extended release oral suspension), which is being recalled, should stop distributing and return it to place of purchase or as directed in the recall notification.

Patients taking RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the U.S. Food & Drug Administration, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals. Please visit the agency’s website for more information at fda.gov

Consumers with questions regarding this recall can contact SUN PHARMA by calling 1-800-818-4555 Monday through Friday between 8:00 am to 5:00 pm EST or e-mailing drug.safetyUSA@sunpharma.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 21, 2020 5:00 PM

“Company name: GHSW, LLC
Brand name: Trader Joe’s
Product recalled: Southwest Style Sweet Potato Saute Bowl
Reason of the recall: Undeclared milk and egg
FDA Recall date: September 21, 2020
Recall details: GHSW, LLC. is voluntarily recalling 1512 units of Trader Joe’s Southwest Style Sweet Pot... See Moreato Sauté Bowl due to undeclared milk and egg allergens in the dressing that are not declared on the label.  People who are allergic to milk and eggs run the risk of serious or life-threatening allergic reaction if they consume this product.

The dressing is located in a pouch found inside the clear 21.5 oz. bowl. These bowls are sold in the refrigerated section of the store. The recalled product(s) were shipped to 36 Trader Joe’s stores in the following states:  AR, CO, KS, LA, NM, OK, TN, and TX. The recall has been isolated to only Southwest Style Sweet Potato Sauté Bowl with the Best By dates 09/23/20, 09/24/20, 09/25/20, 09/26/20, and 09/28/20 on the front of the package.

No other products or lots are affected by this recall. No reports of illnesses or injury have been received to date. The recall was initiated after it was discovered that the dressing containing milk and egg was distributed in packaging that did not declare the presence of milk or egg. GHSW, LLC is urging customers with any milk and egg allergy concerns to return the product to the point of purchase for a full refund or dispose of the recalled products.  GHSW is standing by to answer customer questions at 888-449-9386, M-F, 9 am to 4 pm PST.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

August 31, 2020 4:00 PM

“Company name: Mylan N.V.
Brand name: Mylan
Product recalled: Tranexamic Acid and Amiodarone HCl injections
Reason of the recall: Vials potentially packaged in incorrect cartons
FDA Recall date: August 31, 2020
Recall details: Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan In... See Morestitutional LLC business is conducting a voluntary nationwide recall to the hospital/clinic level of four lots of Amiodarone HCl Injection, USP 450 mg/9 mL, packaged in cartons of 10 single-dose 9 mL vials and Tranexamic Acid Injection, USP 1000 mg/10 mL, packaged in cartons of 10 single-dose 10 mL vials.

These batches are being recalled due to the potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP. The individual vials contained within the cartons are accurately labeled as Amiodarone HCl Injection, USP or Tranexamic Acid Injection, USP. Both of these medications are administered in a hospital setting only by trained healthcare professionals. To date, Mylan has not received any reports of adverse events related to this recall.

Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP are used to treat different conditions. If Tranexamic acid is administered to a patient in place of Amiodarone or vice versa, it could present a risk to patient safety. If Amiodarone HCl Injection is inadvertently administered it could result in low blood pressure and irregular heartbeat, including lower than expected heart rate, which could have immediate life-threatening effects on cardiac function. If treatment with Amiodarone HCl Injection, when needed, is delayed this could result in continued irregular heartbeat and potential life-threatening effects on cardiac function.

If Tranexamic Acid Injection is inadvertently administered it could result in adverse events, including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness. If treatment with Tranexamic Acid Injection, when needed, is delayed this could result in limited to serious and life-threatening bleeding events. Amiodarone HCl Injection, USP is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients’ refractory to other therapy. Tranexamic acid injection is indicated in patients with hemophilia for short term use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

These batches were distributed nationwide in the USA to wholesalers and hospital/clinical pharmacies between April 2020 and July 2020. The recalled batch information is as follows:

NDC #: 67457-153-09
Material Description: Amiodarone HCl Injection, USP
Strength: 450 mg/9 mL
Carton Size: 10 x 9 mL single-dose vials
Lot No.: 191207 / 191221 / 191223 / 200120
Expiry: Nov. 2021 / Nov. 2021 / Nov. 2021 / Nov. 2021

NDC #: 67457-197-10
Material Description: Tranexamic Acid Injection, USP
Strength: 1000 mg/10 mL
Carton Size: 10 x 10 mL single-dose vials
Lot No.: 191207 / 191221 / 191223 / 200120
Expiry: Nov. 2021 / Nov. 2021 / Nov. 2021 / Nov. 2021

Mylan is notifying its wholesalers and hospital/clinic pharmacies by letter and is arranging for return of recalled products to Stericycle. Wholesalers and hospital/clinic pharmacies that have product which is being recalled should stop use/further distribution or dispensing.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 1, 2020 4:38 PM

“The FSIS announced the recall of approximately 1,202 pounds of ready-to-eat (RTE) chicken salad product by Ukrop’s Homestyle Foods due to misbranding and an undeclared allergen. The product may contain almonds, a known allergen, which are not declared on the product label.

The RTE chicken salad i... See Moretem was produced on August 26, 2020. The following product is subject to recall:

- 15-oz. round plastic containers containing “Ukrop’s Chicken Salad” with a sell by date of “09/02/20”.

The product subject to recall bears establishment number “P-19979” inside the USDA mark of inspection. These items were shipped to retail locations in North Carolina, Ohio, Virginia, and West Virginia. The problem was discovered after the firm received a consumer complaint reporting that the product contained almonds.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

FSIS is concerned that some product may be in retailer and consumers’ refrigerators. Retailers who have obtained these products are urged not to sell them. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify that recalling firms are notifying their customers of the recall and that actions are being taken to make certain that the product is no longer available to consumers. Consumers and members of the media with questions about the recall can contact Susan Rowe, Executive Administrator, Ukrop’s Homestyle Foods, at (804) 340-3050.

Check the full recall details on the FSIS website fsis.usda.gov

Source: FSIS
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Reported By SafelyHQ.com User

September 7, 2020 8:36 PM

“The CFIA announced the recall of Frank brand Milk Chocolate Covered Raisins by Canadian Tire Corporation of Canada from the marketplace due to undeclared peanut.

- Frank Milk Chocolate Covered Raisins (300 g). UPC: 6 26394 33920 7. Best Before 2021 MA 07, Lot: 07EUA | Best Before 2021 MA 13, Lot... See More: 13EUA | Best Before 2021 JL 07, Lot: 07GUB | Best Before 2021 APR 21, Lot: 21DUB | Best Before 2021 JL 08, Lot: 08GUB

Check the full recall details on the CFIA website: inspection.gc.ca

Source: CFIA
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Reported By SafelyHQ.com User

September 4, 2020 7:00 AM

“Company name: RLC Labs, Inc
Brand name: RLC Labs
Product recalled: Nature-Throid® and WP Thyroid®
Reason of the recall: Product may be sub potent
FDA Recall date: September 02, 2020
Recall details: RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid® and WP Thyroid® in... See Moreall strengths, all counts of product within current expiry to the consumer level. The products are being recalled because testing of samples from  six (6) lots  by the U.S. Food and Drug Administration found the samples to be sub potent. The product may have as low as 87% of the labeled amount of Liothyronine (T3) or Levothyroxine(T4).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent Nature-Throid® or WP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.

RLC Labs, Inc. has not received any reports of adverse events related to this recall. Nature-Throid® and WP Thyroid® (thyroid tablets, USP) is composed of liothyronine and levothyroxine, and are used to treat hypothyroidism (underactive thyroid). The products subject to recall are packaged in 30, 60, 90, 100 and 1,000 count bottles. To best identify the product, the NDC’s, Product Descriptions, Lot Numbers and Expiration Dates are listed in the link below.

These lots were distributed nationwide in the USA to RLC Labs, Inc.’s direct accounts, including healthcare professionals and retail pharmacies. RLC Labs, Inc. is proactively notifying its wholesalers by email, mail and phone to discontinue distribution of the product being recalled and is arranging for the return of all recalled products. Patients who are currently taking Nature-Throid® and WP Thyroid® should not discontinue use without contacting their healthcare provider for further guidance and/or replacement prescription.

Consumers with questions about the recall can email RLC Labs, Inc. at recall@rlclabs.com or contact RLC Labs, Inc. Customer Service at 1-877-797-7997, Monday through Thursday from 7:00 am to 4:00 pm MST (AZ) and Friday from 7:00 am to 3:00 pm MST (AZ). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online.

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 2, 2020 8:00 PM

“Company name: Sunshine Mills, Inc.
Brand name: Family Pet, Heartland Farms, Paws Happy Life
Product recalled: Dog Food
Reason of the recall: Elevated levels of aflatoxin
FDA Recall date: September 02, 2020
Recall details: Sunshine Mills, Inc. is issuing a voluntary recall of certain dog food pr... See Moreoducts due to levels of Aflatoxin that are potentially above the acceptable limit.  Aflatoxin is a naturally occurring mold by-product from the growth of Aspergillus flavus and can be harmful to pets if consumed in significant quantities. The potential for aflatoxin levels above the acceptable limit in these products was discovered by routine sampling performed by the Louisiana Department of Agriculture and Forestry showing that a sample of a single 4-pound bag of one lot of the product contained elevated levels of aflatoxin. 

No illnesses have been reported in association with these products to date, and no other Sunshine Mills, Inc. pet food products are affected by this announcement. While no adverse health effects related to these products have been reported, Sunshine Mills, Inc. has chosen to issue a voluntary recall of these products as a precautionary measure in furtherance of its commitment to the safety and quality of its products. 

Pets that have consumed any of the recalled products and exhibit symptoms of illness including sluggishness or lethargy combined with a reluctance to eat, vomiting, yellowish tint to the eyes or gums, or diarrhea should be seen by a veterinarian. The affected products were distributed in retail stores nationally.  Retailers who received the recalled lots have been contacted and asked to pull these lots from their inventory and shelves. 

There are no other Family Pet®, Heartland Farms®, or Paws Happy Life® products or other lot codes of these products affected by this precautionary recall. Consumers who have purchased the recalled products should discontinue use of the product and may return the unused portion to the place of purchase for a full refund.

Consumers may contact Sunshine Mills, Inc. Customer Service at (800) 705-2111 from 7AM to 4PM Central Time, Monday through Friday, or by email at customer.service@sunshinemills.com for additional information. This is a voluntary recall being conducted in cooperation with the U.S. Food and Drug Administration. Products affected by this announcement:

+ Family Pet® Meaty Cuts Beef Chicken & Cheese Flavors Premium Dog Food.
- UPC: 3225120694. Size: 4 Lb. Lot codes: TD3 4/April/2020 | TD1 5/April/2020.
- UPC: 3225118078. Size: 14 Lb. Lot codes: TB1 4/April/2020 | TB2 4/April/2020 | TB3 3/April/2020
- UPC: 3225120694. Size: 28 Lb. TB3 3/April/2020
+ Heartland Farms® Grilled Favorites. Beef Chicken & Cheese Flavor.
- UPC: 7015514299. Size: 14 Lb. Lot codes: TB1 4/April/2020 | TB2 4/April/2020
- UPC: 7015514301 Size: 31 Lb. Lot codes: TA2 4/April/2020 | TA3 4/April/2020
+ Paws Happy Life® Butcher’s Choice Dog Food
- UPC: 3680035763. Size: 16 Lb. Lot codes: TA1 4/April/2020 | TA2 4/April/2020

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 1, 2020 4:36 PM

“Fresco Foods Inc. of Tampa, FL is voluntarily recalling ALL units of Ancient Grain Jackfruit Bowl sold at Publix because it may contain an undeclared allergen, FISH (anchovies). People who have an allergy or severe sensitivity to FISH (anchovies) run the risk of serious or life-threatening allergic... See Morereaction if they consume these products.

The allergy alert was initiated after it was discovered that the Ancient Grain Jackfruit Bowl containing Fish was distributed in packaging that did not reveal the presence of fish. Subsequent investigation indicates the problem was caused by sourcing the wrong sub-ingredient.

- Eat Fresco Ancient Grain Jackfruit Bowl. GTIN: 85898800510. Lot/Exp. Date: ALL

Individuals with an allergy or sensitivity to fish (anchovies) should not consume this product. Households that include individuals with an allergy or sensitivity to fish (anchovies) should dispose of the product or return it to the place of purchase for a refund.

Consumers with questions may contact Fresco Foods, Inc. at (813) 551-2100.

Check the full recall details on corporate.publix.com

Source: Publix
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Reported By SafelyHQ.com User

September 5, 2020 12:01 PM

“Company name: CorgioMed LLC
Brand name: Leafree
Product recalled: Hand sanitizer
Reason of the recall: Product is labeled as edible alcohol.
FDA Recall date: September 03, 2020
Recall details: CorgioMed, LLC is voluntarily recalling all lots of Leafree Instant Hand Sanitizer-Aloe Vera, within e... See Morexpiry to the consumer level.  The products are being recalled because they are labeled as “EDIBLE ALCOHOL”. Leafree Hand Sanitizer is an alcohol-based hand rub to be applied externally to reduce bacteria on the skin when soap and water are not available.

Risk Statement: Ingesting hand sanitizer, which is intended for topical use, may result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal. Young children may experience a sharp decrease in blood sugar which may result in death. Pregnant women who ingest alcohol have experienced birth defects and developmental disabilities. Nursing mothers who ingest alcohol in above moderate levels may see developmental, growth and sleep pattern damages in their babies and may experience impaired judgement and ability to safely care for their child.

Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute.  The labeling of this product as ‘edible alcohol’ may promote this behavior. The product is used as a hand sanitizer and is packaged in 100 ml (UPC #6970495860325), 300 ml (UPC #69705860318) and 500 ml (UPC #6970495860301) bottles. 

Product was distributed Nationwide via CorgioMed website. CorgioMed LLC is notifying its distributors and customers by email and is arranging for return or disposal of all recalled products. Distributors and Consumers with questions regarding this recall can contact CorgioMed LLC by emailing to: contact@corgiomed.comor phone: 301-978-3898 from September 1st to September 30th, 2020. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online.

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 2, 2020 11:41 PM

“The FSA announced the recall of Lamb and Carrot Dumplings by Freshasia Foods because they contain crustaceans, which are not mentioned on the label. This means the product is a possible health risk for anyone with an allergy to crustaceans.

FSA advises consumers not to eat the recalled product. I... See Morenstead, return it to the store from where it was bought for a full refund.

+ Freshasia Lamb and Carrot Dumplings. 400g. Batch code: 200402. Best before: 6 April 2021

Freshasia Foods is recalling the above product from customers and has been advised to contact the relevant allergy support organisations, which will tell their members about the recall. The company has also issued a point-of-sale notice to its customers. These notices explain to customers why the product is being recalled and tell them what to do if they have bought the product.

Check the full recall details on food.gov.uk

Source: FSA
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Reported By SafelyHQ.com User