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FDA Classifies Q’Apel Medical Inc.’s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as Class I

On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units of its 072 Aspiration System (also known under the product name “Hippo”, which includes “Cheetah”; collectively, the “product

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fda-classifies-qapel-medical-incs-worldwide-medical-device-recall-and-discontinuation-its-072

 
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Max Mobility / Permobil Expands Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User

Max Mobility/Permobil has expanded the recall of the Speed Control Dial, a wired control option for the SmartDrive MX2+ Power Assist Device due to safety and performance concerns. The recall was originally initiated on December 20, 2024, and has been expanded to address recalled product that may hav

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/max-mobility-permobil-expands-nationwide-recall-smartdrive-speed-control-dial-due-motor-being

 
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Bausch + Lomb Announces Voluntary Recall of enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses in the U.S.

Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced a voluntary recall of intraocular lenses (IOLs) on its enVista platform.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bausch-lomb-announces-voluntary-recall-envista-aspiretm-envista-envytm-and-certain-envistar

 
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Peritoneal Dialysis Set Correction: Baxter Issues Correction for MiniCap Extended Life Peritoneal Dialysis Transfer Sets Due to Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or NDL-PCBs

Use of Baxter MiniCap Extended Life PD Transfer Sets during peritoneal dialysis may expose patients to higher than allowable NDL-PCBAs.

http://www.fda.gov/medical-devices/medical-device-recalls/peritoneal-dialysis-set-correction-baxter-issues-correction-minicap-extended-life-peritoneal