This device is used during an atherectomy to treat patients who have calcified narrowings and blockages in the peripheral arteries.

Sodium Citrate Blood Specimen Collection Tube Conservation Strategies

The FDA recommends conservation strategies to minimize the use of these tubes and maintain the quality and safety of care for patients.

Getinge USA Sales, LLC recalls its Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems due to a risk of harmful chemical exposure.

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

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).

Do not routinely use AFX2 endovascular grafts for patients with abdominal aortic aneurysms.

FDA is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth.

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

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

Listing of Medical Device 2022 Safety Communications

The tests are likely to have a high risk of false results and are not FDA authorized, cleared, or approved.

Cardiovascular Systems, Inc Recalls WIRION Embolic Protection Device Due to Complaints of Filter Breakage During Retrieval

Medtronic is recalling its Synergy Cranial and StealthStation S7 Cranial software due to the potential inaccuracy of the Biopsy Depth Gauge Cycle View.

Covidien, LP (part of Medtronic) is recalling its Puritan Bennett 980 Series Ventilator due to a capacitor manufacturing assembly error.

List of Medical Device recalls in 2022.

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

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

December 27, 2021 – Padagis US LLC announced today it has issued a voluntary nationwide recall to the consumer/user level of the lots of Nitroglycerin Lingual Spray listed in the table below. Out of an abundance of caution, this product is being recalled from the market due to a complaint received t

The FDA is updating information about Getinge’s Maquet/Datascope IABP devices including information about three voluntary recalls.