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Browse Device Recalls

3,428 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,428 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 3,428 FDA device recalls — Class I.

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DateProductReasonClassFirm
Jun 8, 2023 Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60... There have been complaints of endobronchial combustion during therapeutic laser procedures with t... Class I Olympus Corporation of the Americas
Jun 8, 2023 Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150 There have been complaints of endobronchial combustion during therapeutic laser procedures with t... Class I Olympus Corporation of the Americas
Jun 8, 2023 Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q... There have been complaints of endobronchial combustion during therapeutic laser procedures with t... Class I Olympus Corporation of the Americas
Jun 8, 2023 Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q1... There have been complaints of endobronchial combustion during therapeutic laser procedures with t... Class I Olympus Corporation of the Americas
Jun 6, 2023 GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numb... Prior to current established manufacturing practices, higher levels of airborne formaldehyde expo... Class I DATEX--OHMEDA, INC.
Jun 6, 2023 GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator a... Prior to current established manufacturing practices, higher levels of airborne formaldehyde expo... Class I DATEX--OHMEDA, INC.
Jun 5, 2023 Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power... Class I Datascope Corp.
Jun 5, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interru... Class I Datascope Corp.
Jun 5, 2023 Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interru... Class I Datascope Corp.
Jun 5, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power... Class I Datascope Corp.
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during elec... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosu... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosu... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during elec... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosur... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during elect... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
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 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 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180055 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 100380060 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504575 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 100382025 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 100382060 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 100380030 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 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 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 Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585 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 100180060 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565 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 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181030 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 100380055 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 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 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 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 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181065 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 170130 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 170125 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 170055 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 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060 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 Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170145 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC

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.