Browse Device Recalls
3,629 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,629 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 3,629 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 8, 2023 | Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2 | 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, Model Numbers BF-Q170 | 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 BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160 | 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 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... | 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 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... | 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 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 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 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. |
| 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. |
| May 25, 2023 | Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570 | 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 Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170150 | 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 | 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 | Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-... | Raw material issue may cause cardiac panel products to have an average of 30% troponin signal red... | Class I | QUIDEL CARDIOVASCULAR INC |
| 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 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 | Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170120 | 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 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 100380035 | 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 | 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 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 504555 | 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 | Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180045 | 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 100181060 | 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 504580 | 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 Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506535 | 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 | 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 100180060 | 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 100382040 | 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 - Magill, REF 100380040 | 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 100382065 | 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.