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.
Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.
Listing of Medical Device 2022 Safety Communications
Pregnant patients should discuss test results with a health care provider before making any decisions about their pregnancy
Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin glargineyfgn) Injection, 100 units/mL (U-100), which is packaged in a 10 mL vial that is inside a carton. This product is not the branded Semglee vial but the unbranded Insulin Glargine
The U.S. Food and Drug Administration (FDA) wants to increase awareness about the intended use of imaging software for intracranial large vessel occlusion or LVO.
FDA is sharing recommendations and updates to help improve duodenoscope reprocessing.