Avanos Medical CORTRAK*2 Enteral Access System is being recalled because misplaced enteral tubes may cause patient harm.
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SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA
SML Distribution Recalls Unauthorized COVID-19 Direct Antigen Rapid Tests because they are not authorized, cleared, or approved by the FDA.
Mesa Biotech, Inc., Recalls Certain Accula SARS-CoV-2 Tests for Risk of False Positives Caused by Contamination
Mesa BioTech’s Accula SARS-CoV-2 Tests are being recalled because facility contamination may cause them to give false positive results.
Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers
The FDA is evaluating the potential risk of exposure to toxic compounds when using certain Fresenius Medical Care hemodialysis machines
Philips Respironics Issues Voluntary Recall Notification/Field Safety Notice* for the V60 Ventilator Product Family
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
Fagron Inc. Issues Voluntary Nationwide Recall of SyrSpend SF Cherry Due to Microbial Contamination
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
Potential for Internal Pump Malfunction in the Medtronic HVAD System – Letter to Health Care Providers
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.
Potential Risk of Airway Obstruction When Using Certain Electromyogram Endotracheal Tubes – Letter to Health Care Providers
The FDA has received reports of airway obstruction and ventilation failure for certain EMG endotracheal tubes.
