Browse Device Recalls
3,664 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,664 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 3,664 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 170145 | 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 | 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 - 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 | Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180035 | 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 170070 | 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 150035 | 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 - Magill, REF 100380025 | 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 150020 | 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 |
| 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 | 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 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 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 100180030 | 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 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 | 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 170155 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... | Class I | TELEFLEX LLC |
| 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 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 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 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 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 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 Datex Connector, REF TS-E4-GE; Monitor, ... | 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 10, 2023 | ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Def... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Def... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter De... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Card... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable ... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; Implantable Car... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardi... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardiovert... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardi... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Def... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Def... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardiovert... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardio... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
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.