Browse Device Recalls

140 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 140 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 140 FDA device recalls.

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DateProductReasonClassFirm
May 25, 2023 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180050 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF ... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cu... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170090 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170080 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181045 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150025 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cu... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380030 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cu... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380050 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180070 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480030 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380065 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF ... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181055 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150055 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF ... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382055 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382035 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
Apr 28, 2023 Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for us... Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for... Class II TELEFLEX LLC
Apr 12, 2023 Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 400... The product contains an expired diluent vial. If the impacted product is used, the sterility of t... Class II TELEFLEX LLC
Dec 8, 2022 Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasa... Potential for pilot balloon non-inflation or cuff non-deflation. Class II TELEFLEX LLC
Dec 8, 2022 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended ... Potential for pilot balloon non-inflation or cuff non-deflation. Class II TELEFLEX LLC
Dec 8, 2022 Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotrache... Potential for pilot balloon non-inflation or cuff non-deflation. Class II TELEFLEX LLC
Sep 28, 2022 Pilling Wecksorb Cylindrical Sponges Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the a... Class II TELEFLEX LLC
Sep 20, 2022 Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Ki... Product may not be sterile Class II TELEFLEX LLC
Aug 29, 2022 Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19... Incidents of device splitting or detaching during use Class I TELEFLEX LLC
Aug 29, 2022 Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS... Incidents of device splitting or detaching during use Class I TELEFLEX LLC
Aug 29, 2022 Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circ... Incidents of device splitting or detaching during use Class I TELEFLEX LLC
Aug 29, 2022 Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical ga... Incidents of device splitting or detaching during use Class I TELEFLEX LLC
Aug 29, 2022 Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only;... Incidents of device splitting or detaching during use Class I TELEFLEX LLC
Aug 29, 2022 Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS on... Incidents of device splitting or detaching during use Class I TELEFLEX LLC
May 25, 2022 TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen ... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office

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.