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Safety Reports: Medical Devices

Updated:

Real Time Reports

Recall notice

Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits - recalled due to inappropriate premarket or inaccurate test results, USA

2 years ago •source fda.gov • details

Universal Meditech Inc. initiated a nationwide recall of 56,300 Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits. The product(s) have been found to have been distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by… See more

#medicaldevices #unitedstates

Recalls Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits - recalled due to inappropriate premarket or... photo #1
312   Comments Comment

Recall notice

Smith’s Medical CADD Infusion System Infusion Sets for use with CADD pumps - recalled due to alarms issues, USA

3 years ago •source fda.gov • details

Smiths Medical issued an Urgent Medical Device Correction Letter to notify affected customers of two potential issues with CADDTM Infusion System Infusion Sets related to potential lack of delivery or underdelivery and false no disposable attached (NOA) alarms. The letter details the issues, the affected items, the… See more

#recall #medicaldevices #unitedstates

312   Comments Comment

Recall notice

After Burn® Cream and First Aid Kits containing After Burn Cream - recalled due to bacteria, USA

3 years ago •source fda.gov • details

Xiamen, Fujian, GFA Production (Xiamen) Co., Ltd. is voluntarily recalling one lot of Easy Care first aid® AfterBurn ® Cream, 0.9 g single-use packets. The single use packets are sold in boxes of 10 or packaged in certain First Aid kits. This recall is to the consumer… See more

#medicaldevices #unitedstates #cream #sourcream

Recalls After Burn® Cream and First Aid Kits containing After Burn Cream - recalled due to bacteria Xiamen,... photo #1
313   Comments Comment

Recall notice

Detect, Inc. Over the counter Covid-19 Test - recalled due to may give false negative results, USA

3 years ago •source fda.gov • details

Detect, Inc. is voluntarily recalling specific lots of the Detect Covid-19 Test™, their molecular, over-the-counter test used to identify SARS-CoV-2 (the virus that causes Covid-19) in self-collected nasal swabs. The recall affects a total of 11,102 tests shipped to customers from July 26th, 2022 through August 26th,… See more

#coronaviruscovid19 #medicaldevices #recall #unitedstates

Recalls Detect, Inc. Over the counter Covid-19 Test - recalled due to may give false negative results Detec... photo #1
314   Comments Comment

Recall notice

Insulet Corporation Omnipod Automated Insulin Delivery System - recalled due to charging issue, USA

3 years ago •source fda.gov • details

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… See more

#medicaldevices #unitedstates #roll

312   Comments Comment

Recall notice

Insulet Corporation Omnipod DASH Personal Diabetes Managers - recalled due to battery issue, USA

3 years ago •source fda.gov • details

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… See more

#recall #medicaldevices #unitedstates

Recalls Insulet Corporation Omnipod DASH Personal Diabetes Managers - recalled due to battery issue Insulet... photo #1
312   Comments Comment

Recall notice

Gibeck® and Iso-Gard® Bacterial and viral filters - recalled due to Bacterial and viral filters, USA

3 years ago •source fda.gov • details

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… See more

#medicaldevices #recall #unitedstates

312   Comments Comment

Recall notice

Mighty Bliss Electric Heating Pad - recalled due to product safety concerns, USA

3 years ago •source fda.gov • details

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… See more

#recall #amazon #walmart #medicaldevices #unitedstates #sub #ro-tel

Recalls Mighty Bliss Electric Heating Pad - recalled due to product safety concerns Whele LLC, of Boston, MA... photo #1
312   Comments Comment

Recall notice

WatchCare Incontinence management system - Urgent Medical Device Correction due to potential RF interference with other medical devices, USA

3 years ago •source fda.gov • details

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… See more

#blood #medicaldevices #unitedstates #feta #ro-tel

Recalls WatchCare Incontinence management system - Urgent Medical Device Correction due to potential RF inte... photo #1
312   Comments Comment

Recall notice

Family Dollar OTC medical products - recalled due to storage outside of labeled temperature, USA

3 years ago •source fda.gov • details

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… See more

#familydollar #medicaldevices #unitedstates #cream #sub #ham #ro-tel

Recalls Family Dollar OTC medical products - recalled due to storage outside of labeled temperature Family D... photo #1
313   Comments Comment

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