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January 21, 2022 at 12:00 AM
This device is used during an atherectomy to treat patients who have calcified narrowings and blockages in the peripheral arteries.
January 21, 2022 at 12:00 AM
List of Medical Device recalls in 2022.
January 19, 2022 at 12:00 AM
The FDA recommends conservation strategies to minimize the use of these tubes and maintain the quality and safety of care for patients.
January 19, 2022 at 12:00 AM
List of Medical Device recalls in 2022.
January 19, 2022 at 12:00 AM
Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens, which are packaged in a labelled carton of five (5) pens. The product is being recalled due to the potential f
January 19, 2022 at 12:00 AM
Sodium Citrate Blood Specimen Collection Tube Conservation Strategies
January 19, 2022 at 12:00 AM
Getinge USA Sales, LLC recalls its Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems due to a risk of harmful chemical exposure.
January 13, 2022 at 12:00 AM
Do not routinely use AFX2 endovascular grafts for patients with abdominal aortic aneurysms.
January 13, 2022 at 12:00 AM
The FDA is updating our October 28, 2019 safety communication on the use of AFX endovascular grafts with Duraply material (AFX with Duraply or AFX2).
January 13, 2022 at 12:00 AM
Listing of Medical Device 2022 Safety Communications
January 12, 2022 at 12:00 AM
Lohxa LLC is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups to the consumer level. The product is being recalled due to microbial contamination. Use of contaminated product by the elderly, patients with a weakened immune system, or patients at a higher risk of developing li
January 12, 2022 at 12:00 AM
Cranford, New Jersey, Viona Pharmaceuticals Inc., is voluntarily recalling thirty three (33) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. Reason for the recall is an Out of specification result observed for the said product, Lot number M008132, “N-nitroso
January 12, 2022 at 12:00 AM
FDA is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth.
January 12, 2022 at 12:00 AM
Oscor Inc. is voluntarily recalling 14 lots of Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 down to the user level. The Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 have been found to have increased risk of the hub cap and seal on the proximal end of the devic
January 11, 2022 at 12:00 AM
The tests are likely to have a high risk of false results and are not FDA authorized, cleared, or approved.
January 11, 2022 at 12:00 AM
Listing of Medical Device 2022 Safety Communications
January 10, 2022 at 12:00 AM
List of Medical Device recalls in 2022.
January 10, 2022 at 12:00 AM
Cardiovascular Systems, Inc Recalls WIRION Embolic Protection Device Due to Complaints of Filter Breakage During Retrieval
January 06, 2022 at 12:00 AM
Medtronic is recalling its Synergy Cranial and StealthStation S7 Cranial software due to the potential inaccuracy of the Biopsy Depth Gauge Cycle View.
January 06, 2022 at 12:00 AM
List of Medical Device recalls in 2022.
January 05, 2022 at 12:00 AM
Getinge/Datascope/Maquet recalls the Cardiosave IABP after complaints of fluid leaks causing the system to shut down.
January 03, 2022 at 12:00 AM
Covidien, LP (part of Medtronic) is recalling its Puritan Bennett 980 Series Ventilator due to a capacitor manufacturing assembly error.
January 03, 2022 at 12:00 AM
List of Medical Device recalls in 2022.
December 30, 2021 at 12:00 AM
Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g tubes, to the consumer level. This recall ONLY applies to tubes labeled with “Lot AC13786” and “Exp Dec 2022”. No other lots of this product
December 28, 2021 at 12:00 AM
Getinge/Datascope/Maquet recalls the Cardiosave IABP after complaints of fluid leaks causing the system to shut down.