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Browse Device Recalls

59 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 59 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 59 FDA device recalls.

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DateProductReasonClassFirm
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 1.0, 100 per box, 24 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 21 G X 1.5 in YALE DISP, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 10 CC L/L, 100 per box, 12 boxes/case, 1,200/case The prod... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 5 CC L/L, 100 per box, 20 boxes/case, 2,000/case The produ... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.25, 100 per box, 24 b... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 1 CC TB 27 G X 0.5, 100 per box, 30 box... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.0, 100 per box, 15 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Syringe Bulb, 60 CC 50 pcs per case. The products are used to inject fluid... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 10 CC L/S, 100 per box, 12 boxes/case, 1,200/case The prod... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, 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.