MarketPulse

FDA recall

4 articles
BenzingaBenzinga··Vandana Singh

FDA Issues Highest-Risk Recall of Insulet's Omnipod 5 Over Insulin Delivery Defects

FDA classifies Insulet's Omnipod 5 recall as highest-risk due to insulin under-delivery defects. Stock plunges 10.95% amid 476 reported serious injuries.
PODDFDA recallmedical device safety
BenzingaBenzinga··Vandana Singh

FDA Issues Class I Recall for Tandem Diabetes Mobi Pumps Over Insulin Delivery Risk

FDA classifies Class I recall for Tandem Diabetes' Mobi insulin pumps due to false motor failure detection risking insulin delivery interruption.
TNDMFDA recallmedical device
BenzingaBenzinga··Vandana Singh

Boston Scientific Suspends AXIOS Stent Devices Over Safety Concerns

Boston Scientific suspended AXIOS Stent devices after 167 serious adverse events and three deaths linked to deployment failures. FDA directed healthcare facilities to stop using affected devices.
BSXstent delivery devicesAXIOS stents
BenzingaBenzinga··Vandana Singh

FDA Issues Class I Recall for Medline Homecare Beds Over Fire and Shock Hazards

FDA issues Class I recall for Medline homecare beds due to fire and electrical shock hazards. One death linked to overheating cords; company distributing revised instructions instead of removal.
MDLNFDA recallfire hazard