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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Nov 2, 2018 CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for ... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbe... The needle guide bracket may puncture the sterile cover applied over the transducer and bracket d... Class II CIVCO Medical Instruments Co., Inc.
Sep 11, 2013 P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-... FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket... Class II SonoSite, 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.