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Family Dollar OTC medical products - recalled due to storage outside of labeled temperature, USA
2 months ago
Family Dollar is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and inadvertently shipped to certain stores on or around May 1, 2022 through June 10, 2022 due to product being stored outside of labeled temperature requirements. This notice covers the recall of Over-the-Counter Medical Devices. An earlier notice issued July 21, 2022 covered a related recall of Over-the-Counter Pharmaceutical Products. To date, Family Dollar has not received any consumer complaints or reports of illness related to this recall. This recall is being conducted out of an abundance of caution.
- Recalled products:
900260 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT
900794 900794 LS SKYN NON LATEX LUBRICATED CONDOM 3CT
901260 901260 VERIQUICK PREGNANCY TEST 1CT
902343 902343 FIRST RESPONSE 2 CT
903409 903409 SKYN ORIGINAL NON LATEX CONDOM 12CT
903415 903415 SKYN ELITE NON LATEX CONDOM 12CT
939504 939504 VERIQUICK PREGNANCY TEST 1 CT
900752 900752 AT HOME MARIJUANA TEST STRIP
902816 902816 TROJAN ULTRA RIBBED LUBED 3CT
903756 903756 VERIQUICK PREGNANCY TEST 2 CT
999763 999763 TROJAN ULTRA THIN CONDOM LATEX 3CT
998221 998221 SKYN ELITE LARGE NON LATEX CONDOM 12CT
998869 998869 PREFERRED UTI TEST 1 CT
900265 900265 LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT
900531 900531 CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO
999009 999009 B L BIOTRU MULTI PURPOSE SOLUTION 4 FLOZ
902274 902274 GS SALINE SOLUTION 12FL OZ
901443 901443 KY JELLY LUBRICANT 2 FL OZ
901960 901960 OPTI FREE REPLENISH MULTI PURPOSE 2 OZ
999801 999801 SIMPLY SALINE NASAL MIST 3.1 OZ
900457 OPTI FREE PURE MST DSINFCTNG SLTN 4FL OZ
902139 902139 DENTEMP ONE STEP .077OZ
906018 906018 FIXODENT ORG CREAM 2.4OZ
998762 998762 DRTALBOT TDDLR TTHPSTE BRSH TUTTI FRUTTI
905076 905076 CURAD STRNG WATRPRF STRIP 1IN 20CT
906312 906312 GS DENTURE CLEANSER GRN TAB 40CT
999619 999619 FIXODENT ADH CREAM ULTRA MAX HOLD 2.2OZ
999037 999037 CURAD FIRST AID KIT
903377 903377 POLIGRIP POWER MAX HOLD 2.2OZ
999417 999417 NEW SKIN LIQUID BANDAGE CLEAR .3FL OZ
900737 900737 TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT
901239 901239 FIXODENT ORG CREAM TRAVEL .75OZ
906131 906131 POLIDENT DENTURE CLNS TAB 28CT
900334 900334 POLIGRIP ADH CREAM FREE 2.4OZ
906023 906023 GS DENTURE CLEAN OVRNT TAB 40CT
901634 901634 POLIDENT DENTURE CLEANSERS 84 CT
901777 901777 POLIDENT OVERNIGHT WHITENING TAB 28CT
906402 906402 FIXODENT ADH CREAM WITH SCOPE 2OZ
999632 999632 POLIGRIP EXTRACARE ADHESIVE CREAM 2.2OZ
900085 900085 SUPER POLIGRIP ADH CREAM .75OZ
900723 900723 POLIGRIP DENTURE ADHESIVE ORIGINAL 2.4OZ
This recall goes to the retail store level. Not all of the products listed were sent to all stores. Family Dollar has notified its affected stores asking them to check their stock immediately and to quarantine and discontinue the sale of any affected product. Customers that may have bought affected product may return such product to the Family Dollar store where they were purchased without receipt.
This recall does not apply to Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, Washington, Alaska, or Hawaii as Family Dollar does not have any stores in Alaska or Hawaii and no Family Dollar stores in any of the other states received any products subject to this recall. Customers should contact their physician or health care provider if they have experienced any problems that may be related to using these products.
Company name: Family Dollar
Brand name: Multiple brand names
Product recalled: Various OTC medical products
Reason of the recall: Product was stored outside of labeled temperature requirements.
FDA Recall date: September 16, 2022
WatchCare Incontinence management system - Urgent Medical Device Correction due to potential RF interference with other medical devices, USA
1 month ago
Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the WatchCare Incontinence Management System due to potential for radio frequency (RF) interference with other medical devices. The WatchCare System is distributed in the United States.
This Urgent Medical Device Correction applies to... Centrella Bed with WatchCare product number P7900B; WatchCare System for VersaCare Bed Rev. A-J product number P00697901; WatchCare System for VersaCare Bed Rev. K product number P00697902; WatchCare System for Progressa Bed product number P00697903; and WatchCare System for Centrella Bed product number P00697905.
The WatchCare system is designed to discreetly alert the caregiver of an incontinence event. Although the WatchCare system has been developed to comply with the most recent RF standards, it radiates RF that might affect other devices in the vicinity, including devices on both patients and staff members. This RF interference could result in erroneous readings or additional malfunctions of these other devices and could therefore result in inappropriate medical intervention. Depending on the intended use of the device that malfunctions, there may be different hazardous situations that could occur. This product is manufactured by Hillrom, which was acquired by Baxter in late 2021. Baxter is also issuing an updated customer notification letter for this correction, replacing the previous letter issued on September 30, 2022. To date, interference in all cases but two is known to have occurred at distances less than one meter. There is insufficient data about distance on the remaining two reported interferences.
Of note, Baxter is informing users of the following potential hazards, though additional devices may be affected:
- Insulin pump/blood glucose sensor: Sensor readings can be affected and result in overdosing of insulin related to incorrect high glucose readings; as a precaution, users should be vigilant of any erratic or incorrect (high or low) glucose level(s) or insulin dosing events
- Fetal monitor/doppler: May cause "phantom" incorrect fetal heart tone readings up to 200 bpm; as a precaution, users should be vigilant of any erratic or incorrect (high or low) fetal heart tones
- Telemetry devices: Could cause telemetry “artifact” of unknown specificity; as a precaution, users should be vigilant of any telemetry rhythm displays that do not match patient’s clinical presentation
- Bladder scanner: May cause interference of unknown specificity; as a precaution, users should be vigilant of any potential false (elevated or low) residual urine volume readings
- Infusion injection pump: May cause interference of unknown specificity; as a precaution, users should be vigilant of any erratic or incorrect dosing events
Since this issue may affect blood glucose sensors, insulin pumps, fetal monitors, and general infusion pumps among other devices, serious harm or death may occur. This issue can affect medical devices on patients as well as staff caring for patients. No serious injuries or deaths have been reported. Users and facilities should immediately locate all affected devices and stop use of all WatchCare system accessories where possible until this functionality is temporarily disabled and while Baxter continues to work to determine the cause of this problem. Baxter will contact users to arrange for WatchCare to be temporarily disabled. Until all RF capabilities are disabled and/or all devices are removed from clinical care areas, be aware that RF emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to, insulin pumps/blood glucose sensors, fetal monitor/dopplers, infusion pumps, telemetry devices, and bladder scanners).
Please double-check all unexpected or atypical results and monitor infusions closely, if possible. Until this issue is resolved, use standard, non-RF-based, incontinence management pads. Baxter is monitoring reports of RF interference and validating the impact the WatchCare device may have on other devices in the vicinity. Baxter is also investigating improvement opportunities and will provide a follow-up communication to users once available.
Baxter is voluntarily issuing this Urgent Medical Device Correction with the knowledge of the U.S. Food and Drug Administration.
Company name: Baxter International Inc.
Brand name: WatchCare
Affected product: Incontinence management system
Reason of the Urgent Medical Device Correction: Potential for radio frequency (RF) interference with other medical devices.
FDA Recall date: October 24, 2022
Whele LLC, of Boston, MA, is voluntarily recalling its Mighty Bliss Electric Heating Pad, due to product safety concerns. Use of this product may lead to burns, mild shocks, or rashes/irritation. Product was sold via Amazon.com and Walmart.com. We received 286 complaints between July 2021 to September... 2022 related to the product overheating, sparking, burning, or presenting other electrical problems. 31 of these complaints reported injuries such as mild shocks, burns, and rashes or irritation.
This recall applies to 544,212 Mighty Bliss Electric Heating Pad units manufactured between 08JAN21 to 03JAN22 and distributed from 29JUL21 through 21JUL22. Model Numbers and Descriptions Below:
- MB-001 (NA-H1121B): Large (12” x 24”) Blue Electric Heating Pad
- MB-002 (NA-H21C): Extra-Large (20” x 24”) Blue Electric Heating Pad
- PE-MtyBls-HeatPad-12x24-Gry-V2(NA-H1121B): Large (12” x 24”) Grey Electric Heating Pad
The product lot number can be found directly on the heating pad listed in black text beneath the product instructions.
Company name: Whele LLC
Brand name: Mighty Bliss
Product recalled: Heating pads
Reason of the recall: Use of product may lead to burns, mild shocks, or rashes and irritation
FDA Recall date: October 24, 2022
This recall has been initiated due to product safety concerns. Use of this product may lead to electric shocks and/or skin irritation, rashes, blisters, or burns. Severe burns may result in infection or formation of scar tissue.
Customer/User Immediately cease use of the product. Distributor Immediately examine your inventory and quarantine the product subject to recall. We will be in contact to gather any remaining inventory for destruction. If you may have further distributed this product, please identify your customers and notify them within two (2) business days of this product recall.
Gibeck® and Iso-Gard® Bacterial and viral filters - recalled due to Bacterial and viral filters, USA
1 month ago
Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced a worldwide recall of affected lots of the below-referenced Gibeck® Iso-Gard® Filter products. The Gibeck® Iso-Gard® Filter is a bacterial and viral filter, intended for connection to respiratory equipment... in intensive care units and operating theatres to protect the equipment from potential airborne contaminants. If the filter splits or detaches during use, the functionality and efficiency of the device may be compromised, potentially resulting in a leakage and insufficient air supply to the patient with potential desaturation.
The products involved in the recall are listed below. Additional detail about how to identify the affected products is available in the recall letter.
Product Codes: 19012. Commercial Name: Iso-Gard® Filter S with Expandi-Flex/Elbow
Product Codes: 19012T. Commercial Name: Iso-Gard® Filter S with Expandi-Flex/Elbow, Tethered Cap
Product Codes: 191667-000100. Commercial Name: Filter + Catheter Mount
Product Codes: 19211; 19212. Commercial Name: Iso-Gard® Filter S
Product Codes: 19261; 19272. Commercial Name: Iso-Gard® Filter S with Expandi-Flex
Product Codes: 19261T; 19262T; 19272T. Commercial Name: Iso-Gard® Filter S with Expandi-Flex, Tethered Cap
Product Codes: 19211T; 19212T. Commercial Name: Iso-Gard® Filter S, Tethered Cap
Note: This recall is for specific lots of the above-referenced product codes.
In case you experienced harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: Teleflex Incorporated
Brand name: Gibeck® and Iso-Gard®
Product recalled: Bacterial and viral filters
Reason of the recall: Bacterial and viral filters
FDA Recall date: November 04, 2022
1 month ago
Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), announced on October 17, 2022, a Medical Device Correction for all Omnipod DASH® Personal Diabetes Managers (PDMs) distributed globally. This action was taken voluntarily with the knowledge of the FDA and other regulatory agencies. Insulet received reports from Omnipod... DASH users regarding PDM battery issues, including battery swelling and leakage, and in rare cases, extreme overheating, which has resulted in reports of fire.
The Company’s investigation determined that the Omnipod DASH PDM is at increased risk of malfunction if overcharged beyond the maximum battery voltage, which could potentially lead to serious injury or death. There have been 50 complaints about this issue. No serious injuries or deaths have been reported as a result of this potential issue. As previously communicated to Omnipod DASH users, Insulet has identified an update to the Omnipod DASH PDM that will resolve this issue.
The Company expects to begin shipping updated Omnipod DASH PDMs to all current Omnipod DASH customers in the coming months. All affected Omnipod DASH consumers are being notified by email and local mail. Insulet has been providing customers with instructions to help reduce the risk of PDM battery issues.
This Medical Device Correction does not affect Omnipod DASH Pods, the Omnipod® Insulin Management System, or the Omnipod® 5 Automated Insulin Delivery System.
In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: Insulet Corporation
Brand name: Insulet Corporation Omnipod DASH
Product recalled: Personal Diabetes Managers
Reason of the recall: Battery issue: battery swelling, leakage, and in rare cases, extreme overheating, which has resulted in reports of fire.
FDA Recall date: November 05, 2022
3 weeks ago
Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), today announced a Medical Device Correction for the Omnipod® 5 Automated Insulin Delivery System because of an issue with the Omnipod 5 Controller charging port and cable. This does not impact the Omnipod 5 Pod, the Omnipod® DASH Insulin... Management System, the Omnipod® Insulin Management System, or compatible Android smartphone devices that have the Omnipod 5 App installed. These actions are taken voluntarily with the knowledge of the FDA. Insulet has received 24 reports that the Omnipod 5 Controller charging port (USB-C port) or cable (USB cable) are melting, deforming, or discoloring due to heat generated by a poor connection between the cable and the port.
The excess heat may cause minor burns if those areas of the Controller are touched or could lead to fire. No serious injuries have been reported to Insulet as a result of this issue.
Omnipod 5 users are being notified by email with instructions on how to detect and reduce the risk of an issue with the charging port or cable.
In case you experienced issues with this product, it is important to report it.
Company name: Insulet Corporation
Brand name: Insulet Corporation Omnipod
Product recalled: Automated Insulin Delivery System
Reason of the recall: Issue with the Omnipod 5 Controller charging port and cable
FDA Recall date: November 15, 2022
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Nestlé Purina PetCare Company is voluntarily recalling a limited amount of Purina Pro Plan Veterinary Diets EN Gastroenteric Low Fat (PPVD EN Low Fat) prescription wet dog food in 13.4 oz cans due to a labeling error. For a brief period on September 15, 2022, cans of... a different complete and balanced adult dog food, Purina ONE True Instinct Tender Cuts In Gravy With Real Turkey & Venison wet dog food, were labeled as PPVD EN Low Fat in one of our factories. The mislabeled diet is safe to feed, but it is not the intended formula for dogs requiring a prescription PPVD EN Low Fat diet, who may have sensitivities to traditional diets or difficulty digesting fat. While we have not received any reports to date of illness or injury to dogs fed this mislabeled product. The affected product was available by prescription only and distributed through veterinary clinics and other retailers with the ability to validate a prescription.
You can identify the mislabeled product by the UPC (38100 17599), production code (22581159 L4TR6) and “Best Before Sept 2024” date on the bottom of each PPVD EN Low Fat can.
We became aware of the issue after being contacted by several pet owners who observed the texture of food in their PPVD EN Low Fat cans was not the same as previous meals. The mislabeled product contains chunks in gravy, while the correct product looks more like a pate consistency.
We are conducting this voluntary recall as a precaution. We have asked our veterinary and other retail partners to remove the affected product. We also recommend that you discard any of the affected product you may have, and we will replace it as quickly as possible.
No other Purina products are impacted by this voluntary recall. We apologize to pet owners for any concerns or inconvenience this situation has caused. We’re pet owners too, and we know how important the health and well-being of our pets is, which is what led us to make this decision. We are taking action to investigate and notify pet owners and veterinarians of the situation. At Purina, pets always come first.
Company name: Nestle Purina PetCare Company
Product recalled: Purina Pro Plan Veterinary Diets EN Gastroenteric Low Fat (PPVD EN Low Fat) prescription wet dog food
Reason of the recall: Mislabeling / Labeling error
FDA Recall date: December 02, 2022
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