Browse Device Recalls
3,528 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,528 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 3,528 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530 | 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 | 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 | 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 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 | 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 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 Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506540 | 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 | 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 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 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 170130 | 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 | 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 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 1700100 | 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 | Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150030 | 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 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 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 | 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 | 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 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 150020 | 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 | 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 | 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 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 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 Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; 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 |
| 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 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 | 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 | ARROW Endurance Extended Dwell Peripheral Catheter System | Potential for catheter separation or leakage | Class I | ARROW INTERNATIONAL 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.