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 |
|---|---|---|---|---|
| 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 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 170085 | 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 100380045 | 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 100382045 | 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 150020 | 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 | 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 | 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 | Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560 | 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 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 - Murphy, REF 100382050 | 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 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 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 | Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506545 | 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 | RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480040 | 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 | 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 | 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 |
| May 25, 2023 | Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170075 | 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 100180065 | 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 | RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480025 | 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 170095 | 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 170155 | 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 | 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 | 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 170135 | 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 100382035 | 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 506550 | 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 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 100181040 | 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 19, 2023 | TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; ... | There is a potential reduction of energy reaching patient during defibrillation, potential contac... | Class I | GE Healthcare Finland Oy |
| May 19, 2023 | TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter | There is a potential reduction of energy reaching patient during defibrillation, potential contac... | Class I | GE Healthcare Finland Oy |
| May 19, 2023 | TruSignal Wrap Sensor, REF TS-W-D; Oximeter | There is a potential reduction of energy reaching patient during defibrillation, potential contac... | Class I | GE Healthcare Finland Oy |
| May 19, 2023 | TruSignal Ear Sensor, REF TS-E-D; Oximeter | There is a potential reduction of energy reaching patient during defibrillation, potential contac... | Class I | GE Healthcare Finland Oy |
| May 19, 2023 | TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear | There is a potential reduction of energy reaching patient during defibrillation, potential contac... | Class I | GE Healthcare Finland Oy |
| May 19, 2023 | ARROW Endurance Extended Dwell Peripheral Catheter System | Potential for catheter separation or leakage | Class I | ARROW INTERNATIONAL Inc. |
| May 19, 2023 | TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter | There is a potential reduction of energy reaching patient during defibrillation, potential contac... | Class I | GE Healthcare Finland Oy |
| May 19, 2023 | TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs;... | There is a potential reduction of energy reaching patient during defibrillation, potential contac... | Class I | GE Healthcare Finland Oy |
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.