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Browse Device Recalls

15 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 15 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 15 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 CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusabl... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08,... The needle guide bracket may puncture the sterile cover applied over the transducer and bracket d... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for u... The needle guide bracket may puncture the sterile cover applied over the transducer and bracket d... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket wit... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket wit... 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.
Nov 2, 2018 CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket wit... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable ... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracke... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales re... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-st... Class II CIVCO Medical Instruments Co., 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.