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Chengdu Ai Qin Colored contact lenses - recalled due to being distributed without FDA clearance, USA

June 24, 2020 6:00 PM

United States

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 initiated 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

Reported By SafelyHQ.com User
More incidents from:
Medical Devices
United States

Related Reports

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 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

October 27, 2020 12:00 PM

“An employee at the OHM BOCES Bridges program facility recently tested positive for COVID-19

Source: wktv.com See Less
Reported By SafelyHQ.com User

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“Company name: Sunshine Mills, Inc.
Brand name:
Product recalled: Pet Food
Reason of the recall: May Contain Aflatoxin
FDA Recall date: October 08, 2020
Recall details: Company Announcement Sunshine Mills, Inc. is expanding its voluntary recall of certain pet food products that were made with c... See Moreorn that contained Aflatoxin at levels above FDA’s action levels. This is an expansion of the recall initiated September 2, 2020, after an investigation conducted along with the U.S. Food and Drug Administration determined that additional corn-based pet food products produced between April 3, 2020 and April 5, 2020 may contain corn from a single load of corn with elevated levels of aflatoxin. 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. 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.

Sunshine Mills, Inc. has chosen to expand its voluntary recall to include these additional products as a precautionary measure in furtherance of its commitment to the safety and quality of its products. Pets with aflatoxin toxicity (aflatoxicosis) may show symptoms of illness including sluggishness or lethargy combined with a reluctance to eat, vomiting, yellowish tint to the eyes or gums, diarrhea, and in some cases, death. Pets experiencing any of these symptoms after consuming the recalled products should be seen by a veterinarian.

The affected products were distributed in retail stores within the United States. Principle Super Premium Natural Dog Food is exported exclusively to a distributor in Japan. Sportsman’s Pride Maintenance Adult Formula Dog Food is also exported to a distributor in Japan and Colombia. Retailers who received the recalled lots have been contacted and asked to pull any remaining inventory of these lots from their shelves. There are no other Champ®, Field Trial®, Good Dog, Hunter’s Special®, Old Glory®, Paws Happy Life®, Pet Expert, Principle, Retriever®, River Bend, Sportsman’s Pride®, Sprout®, Thrifty®, Top Runner® or Whiskers & Tails products or other lot codes of these products affected by this voluntary recall. The lot codes can be located on the back of each bag.

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. The expansion of this voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration. You can see the products affected by this announcement in the link below.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

October 2, 2020 5:00 PM

“Company name: Ashtel Studios
Brand name: Smart Care
Product recalled: Hand sanitizer packaged in 0.84 oz. pouches
Reason of the recall: Product is packaged in containers resembling a food and drink pouch
FDA Recall date: October 02, 2020
Recall details: Company Announcement Ashtel Studios has a... See Morennounced a voluntary recall of all lots of licensed hand sanitizer packaged in .84 oz containers resembling food and drink pouches labeled with various children’s characters listed in the table below to the consumer level.

The products are being recalled because they are packaged in containers resembling food and drink pouch. The recall does not affect any other Hand Sanitizer products from Ashtel Studios.

Product Size NDC
PAW Patrol Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-042-01
JoJo Siwa Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-044-01
Hot Wheels Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-045-01
Barbie Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-046-01
Trolls Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-047-01
Minions Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-043-01

Ingesting hand sanitizer, which is intended for topical use, could potentially 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. 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. Ashtel Studios has received no reports of adverse reactions.

The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available and is packaged in 0.84 oz pouches. The product can be identified by examples of the products pictured below. Product was distributed to selected retailers in the United States and Canada.

Ashtel Studios has provided written notification to its distributors and retailers and is alerting customers via this voluntary recall. While the product is not available for purchase, if a consumer has product which is being recalled they are advised to destroy it immediately.

Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User

October 14, 2020 9:00 PM

“Company name: Hadson Toko Trading Co., Inc.
Brand name: Eishindo
Product recalled: Jelly Cups
Reason of the recall: Product poses a choking hazard.
FDA Recall date: October 14, 2020
Recall details: HADSON (TOKO) TRADING CO., INC. OF MASPETH, NY is recalling its 28.2oz (800g) bags of EISHINDO MI... See MoreNI CUP JELLY (50 pcs) (迷你果凍杯(大)) due to the product being a potential choking hazard based off of its product size and consistency. Small jelly cups have previously been implicated in choking deaths of children.

The recalled jelly cups were distributed nationwide in retail food stores and are sold in large clear bags of 50 jelly cups. The UPC code is, “4970481000034,” Product code is, “E007.” No incidents of consumers choking have been reported to date in connection with this product. The potential choking hazard was noted after discussion with a representative from the Food and Drug Administration.

Consumers who have purchased 28.2oz (800g) bags of EISHINDO MINI CUP JELLYS are urged to return them to the store where they were purchased for a full refund or throw them away in a sealed package inside a secure garbage can with a tight fitting lid. Consumers who have questions or concerns may contact the company at 718-628-6761 Monday thru Friday between 8AM and 6PM EST.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 30, 2020 1:00 PM

“Company name: Estado de México, México, DMM VISSION, S.A. de C.V
Brand name: Cleaner
Product recalled: Cleaner Hand Sanitizer
Reason of the recall: Potential Presence of Methanol (Wood Alcohol)
FDA Recall date: September 30, 2020
Recall details: Company Announcement Estado de México, México, D... See MoreMM VISSION, S.A. de C.V. is voluntarily recalling five lots of Cleaner Hand Sanitizer, 500 mL and 1,200 mL plastic clear bottles with white tops currently in US distribution to the consumer level. This recall is being initiated out of abundance of caution due to detection of methanol (wood alcohol) in hand sanitizer sample manufactured at the same facility. Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. To date DMM VISSION has not received reports of adverse events related to this recall. The product is used as a hand sanitizer and are packaged in 500ml and 1200ml plastic clear bottles with white tops. The lot numbers are LC2020407, LC2020408, LC2020502, LC2020504, LC2020507.  This product was first distributed nationwide to wholesale distributors on April 27, 2020 and finished on June 9th, 2020. The recalled products are as follows:
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User

October 22, 2020 7:00 PM

“Company name: COMERCIAL MEXICANA INNTERNATONAL INC
Brand name: TROPIQUE
Product recalled: ASSORTED FRUIT JELLY BAG & JELLY ANIMAL JAR
Reason of the recall: Potential Choking Hazard
FDA Recall date: October 22, 2020
Recall details: FDA Announcement Comercial Mexicana International Inc. in... See MoreBethpage New York is recalling the product because it may pose a choking hazard. Small jelly cups containing seaweed extract (carrageenan) has been identified as a potential choking hazard in children No incidents of consumers choking have been reported to date in connection with this problem. The potential choking hazard was discovered during a routine inspection by the New York State Department of Agriculture and Markets, Food Safety and inspection. The recalled jelly cups were sold in NY, NJ, CT, PA retail stores. The recall products are:
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User

October 5, 2020 2:00 PM

“Company name: Marksans Pharma Limited
Brand name: Time-Cap Labs Inc.
Product recalled: Metformin Hydrochloride for Extended-Release Tablets, USP 500 mg and 700 mg
Reason of the recall: Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
FDA Recall date: October 05, 2020
Recall detai... See Morels: Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day, therefore, out of an abundance of caution, an additional 76 lots are being recalled.

Risk Statement: 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 found in water and foods, including meats, dairy products and vegetables. Marksans Pharma Limited has not received any reports of adverse events that have been related to this recall. Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg are indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles with the following NDC#s in different packing configurations
- Metformin Hydrochloride Extended-Release Tablets, USP 500mg:
90 counts: 49483-623-09
100 counts: 49483-623-01
500 counts: 49483-623-50
1000 counts: 49483-623-10
- Metformin Hydrochloride Extended-Release Tablets, USP 750mg:
100 counts: 49483-624-01

The affected Metformin Hydrochloride Extended-Release Tablets, USP 500mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘101’ on one side and plain on the other side and Metformin Hydrochloride Extended-Release Tablets, USP 750mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘102’ on one side and plain on the other side.

Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750 mg were distributed by Time-Cap Labs, Inc. (located at 7 Michael Avenue, Farmingdale, New York 11735) nationwide in the USA to wholesalers who further distributed to pharmacies.

Marksans Pharma Limited is notifying its distributors and customers by issuing notification letter and press release and is arranging for return/replacement etc. of recalled product lots. Distributors //customers that have affected lots of Metformin Hydrochloride Extended- Release Tablets, USP 500mg & 750mg those are being recalled should return to place of purchase. The lot # can be located on the side panel of bottle labels as well as shipper/case labels.

Consumers with questions regarding this recall and return can contact Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc., located at 7 Michael Avenue, Farmingdale, New York 11735, by phone number 631-753-9090; ext. 160, [Monday to Friday 8am-5pm EST] or e-mail address imcgregor@timecaplabs.com.

Consumers taking these recalled product lots of Metformin ER Tablets should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional. Consumer 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.

Check the full recall details and list of products on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

Unmasked employees, Wintrust Bank - Sauganash, West Peterson Avenue, Chicago, IL, USA

Wintrust Bank - Sauganash, West Peterson Avenue, Chicago, IL, USA

October 12, 2020 6:24 PM

“Walked in. Teller had mask on only over nose. She pulled it up as we approached. The other teller was masked, but this one was reckless and didn't care that co-workers and customers had to breathe in her disgusting breath? I asked a very simple account question and was told to talk to a personal ban... See Moreker. I turned to where she pointed and there sat an unmasked elderly female employee. As I approached her I said put on your mask. She replied that the little plastic partition was enough. I looked at her very shocked and she put on her mask. I refused to sit at her guest chair as it was within about 2 feet of her reckless, unmasked exhaling just moments before. She then immediately took pf her.mask, again putting her co-workers and me at risk, as well as anyone entering. Do they not know about aerosol spread? Needless to say we are closing both we have accounts there. See Less
Reported By SafelyHQ.com User

October 7, 2020 12:00 PM

“Additional 4 employees confirmed positive for Covid-19 at Amy's Kitchen in Jackson County. Investigation Start Date: 7/28/2020 , with the most recent onset of: 9/29/2020 New Cases of: 4

Source: www.oregon.gov See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, United States Postal Service, 413 East Maumee Street, Adrian, Michigan 49221, USA

United States Postal Service, 413 East Maumee Street, Adrian, Michigan 49221, USA

October 13, 2020 12:00 PM

“1) Masks for COVID-19 are only worn for brief periods following service talks from upper management, but on an average day, only 10 out of 60 employees wear masks in the facility. Risk of spread the highest in the morning when everyone is present and in close proximity situations such as the traine... See Morer training an employee while both are unmasked.

2) Carriers are not wearing masks into buildings when delivering mail.

3) Customers are not wearing masks to enter the facility.

4) Clerks are unable to wash their hands on a regular basis.


Source: Osha.gov | Receipt Date: 2020-09-17
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Reported By SafelyHQ.com User