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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 9 FDA device recalls.

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DateProductReasonClassFirm
Oct 20, 2014 ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drain... PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f... Class II Pfm Medical Inc
Oct 20, 2014 ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT ... PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f... Class II Pfm Medical Inc
Oct 20, 2014 Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage... PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f... Class II Pfm Medical Inc
Oct 20, 2014 Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product... PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f... Class II Pfm Medical Inc
Oct 20, 2014 Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta P... PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f... Class II Pfm Medical Inc
Oct 20, 2014 Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage... PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f... Class II Pfm Medical Inc
Oct 20, 2014 ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pf... PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f... Class II Pfm Medical Inc
Oct 20, 2014 6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT P... PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f... Class II Pfm Medical Inc
Oct 20, 2014 ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P090800... PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f... Class II Pfm Medical Inc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.