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Browse Device Recalls

163 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 163 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 163 FDA device recalls.

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DateProductReasonClassFirm
May 17, 2024 Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260 The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... Class II B Braun Medical Inc
May 17, 2024 Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251. The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... Class II B Braun Medical Inc
Sep 1, 2022 Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive ant... Potential for leakage at the catheter hub. Class II B Braun Medical Inc
Feb 7, 2022 PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be ... Units not properly inspected prior to release to the market, may not function as indicated in the... Class II B Braun Medical Inc
Jan 28, 2022 Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Co... Firm learned of the potential for cracks to form in the conductivity sensors during use, which ma... Class II B Braun Medical Inc
Jan 28, 2022 Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Co... Firm learned of the potential for cracks to form in the conductivity sensors during use, which ma... Class II B Braun Medical Inc
Apr 10, 2017 CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units eac... B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential f... Class II B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Seria... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The D... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product ... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun 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.