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Safety Reports: Medical Devices

Updated:

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

1 year ago •source fda.gov • details

Recall notice

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

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

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

2 years ago •source fda.gov • details

Recall notice

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

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

2 years ago •source fda.gov • details

Recall notice

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

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

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

2 years ago •source fda.gov • details

Recall notice

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

#recall #medicaldevices #unitedstates

312

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

2 years ago •source fda.gov • details

Recall notice

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

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

Mighty Bliss Electric Heating Pad - recalled due to product safety concerns photo #1
312

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

2 years ago •source fda.gov • details

Recall notice

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

WatchCare Incontinence management system - Urgent Medical Device Correction due to potential RF interference with other medical devices photo #1
312

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

2 years ago •source fda.gov • details

Recall notice

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

Family Dollar OTC medical products - recalled due to storage outside of labeled temperature photo #1
313

Philips Respironics CPAP or Bi-Level PAP therapy masks - recalled due to potential risk of serious injury, USA

2 years ago •source fda.gov • details

Recall notice

These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

Royal Philips’ (NYSE: PHG; AEX: PHIA) subsidiary Philips Respironics is alerting… See more

#blood #recall #medicaldevices #unitedstates #sub #hunts

Philips Respironics CPAP or Bi-Level PAP therapy masks - recalled due to potential risk of serious injury photo #1
312

Intraosseous Products - recalled due to limited or non-functioning intraosseous access, USA

2 years ago •source fda.gov • details

Recall notice

BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on the BDTM Intraosseous Needle Set Kits, BDTM Intraosseous Manual Driver Kits and BDTM Intraosseous Powered Drivers. Certain lots within the expiration date of these intraosseous products may result in the following:… See more

#medicaldevices #unitedstates

312

Volara System (home care) - recalled due to possible risk of oxygen desaturation, USA

2 years ago •source fda.gov • details

Recall notice

Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Volara System (home care) to reinforce important safety information regarding a possible risk of decrease in oxygen levels (oxygen desaturation) or injury that may result in lung tissue damage due to over-expansion… See more

#medicaldevices #unitedstates

312

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