On January 5, 2022, CorneaGen discovered that Cornea Patch Grafts were obtained from a donor who tested reactive for HIV-1/HIV-2 Plus O antibody and were shipped prior to being medically cleared.

Teva Pharmaceuticals USA has initiated a voluntary nationwide recall of a single lot of Anagrelide Capsules, USP 0.5 mg (Lot number GD01090), to the consumer level in the United States. This voluntary recall was initiated due to dissolution test failure detected during routine stability testing. No

CorneaGen is voluntarily recalling the entire lot of Scleral Patch Grafts obtained from (Lot Number) W419221008338

Listing of the 2022 Biologics Recalls

Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall

This update provides additional information on the recall and recommendations for people who use repaired and replaced devices.

Woodside Acquisitions Inc. recalls COVID-19 Rapid Test Kits because they are not authorized, cleared, or approved by the FDA.

Avanos Medical CORTRAK*2 Enteral Access System is being recalled because misplaced enteral tubes may cause patient harm.

The FDA is warning people not to use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests. The test’s performance has not been adequately established.

SML Distribution Recalls Unauthorized COVID-19 Direct Antigen Rapid Tests because they are not authorized, cleared, or approved by the FDA.

Mesa BioTech’s Accula SARS-CoV-2 Tests are being recalled because facility contamination may cause them to give false positive results.

The FDA is evaluating the potential risk of exposure to toxic compounds when using certain Fresenius Medical Care hemodialysis machines

Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that its subsidiary Philips Respironics is notifying customers of its V60/V60 Plus and V680 ventilators about a potential issue with the electrical circuit in these ventilators that controls the 35V power sup

St. Paul, Minnesota, Fagron Inc. (“Fagron”) is voluntarily recalling two lots of SyrSpend SF Cherry to the hospital, pharmacy, and distributor level out of an abundance of caution. The affected lots are potentially contaminated with Burkholderia gladioli. Burkholderia gladioli is an opportunistic pa

Medtronic has stopped the sale and distribution of HVAD because the internal pump may delay or fail to restart.

The FDA is issuing this letter to ensure you are aware of this defect and the recommended actions to take to manage the care of patients currently implanted with a Medtronic HVAD system.

COVID-19 Ag Rapid Tests are being recalled because they may have been distributed to unauthorized, non-CLIA-certified users.

The FDA has received reports of airway obstruction and ventilation failure for certain EMG endotracheal tubes.

The capsule at the end of the delivery catheter used to place Harmony’s pulmonary valve may come loose during placement due to a bond break.