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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Mar 23, 2021 Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, RE... Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus pe... Class II Bioseal Corporation
Mar 23, 2021 Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, RE... Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus pe... Class II Bioseal Corporation
Mar 23, 2021 Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, RE... Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus pe... Class II Bioseal Corporation
Aug 15, 2019 Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, S... The reported stress crack in the port of the swivel elbow where the flip cap is inserted could re... Class II Bioseal Corporation
Oct 18, 2017 Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (... Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled... Class II Bioseal Corporation

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.