Browse Device Recalls
39,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,969 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 39,969 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 15, 2024 | Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm) | When using those products you may experience difficulties to extend or retract the laser fiber, a... | Class II | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. |
| Jan 12, 2024 | 3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with u... | 3M has added the following cautionary statement regarding the use of the product: "Caution - T... | Class II | 3M Company - Health Care Business |
| Jan 12, 2024 | 3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with u... | 3M has added the following cautionary statement regarding the use of the product: "Caution - T... | Class II | 3M Company - Health Care Business |
| Jan 11, 2024 | Colonoscope, Model Number PCF-H190L. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lu... | European version of microcatheter were distributed within US which contain a different "Indicatio... | Class II | Micro Therapeutics, Inc. |
| Jan 11, 2024 | Colonoscope, Model Number PCF-H190TL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lu... | European version of microcatheter were distributed within US which contain a different "Indicatio... | Class II | Micro Therapeutics, Inc. |
| Jan 11, 2024 | Colonoscope, Model Number PCF-HQ190L. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide... | The device has a grip detail (right angle latch) out of specification causing the bur to not adeq... | Class II | Brasseler USA I Lp |
| Jan 11, 2024 | Colonoscope, Model Number CF-HQ190I. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-Q180AL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number CF-HQ190L. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-H180AL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number CF-H180AL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number CF-Q180AL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-H190DL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | Synapse PACS - Version 7.2.200 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, withou... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | Synapse PACS - Version 7.3.000 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, R... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Dete... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | Synapse PACS - Version 7.1.000US | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | Synapse PACS - Version 7.2.000 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, A... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | Synapse PACS - Version 7.1.000 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.2.100 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 9, 2024 | Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL | Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jan 9, 2024 | Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Sha... | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... | Class II | Silex Medical, LLC |
| Jan 9, 2024 | VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-010... | The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Det... | Class I | Ventec Life Systems, Inc. |
| Jan 9, 2024 | Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft a... | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... | Class II | Silex Medical, LLC |
| Jan 9, 2024 | DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic pr... | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Aesculap Inc |
| Jan 9, 2024 | Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and... | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... | Class II | Silex Medical, LLC |
| Jan 9, 2024 | DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparo... | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Aesculap Inc |
| Jan 9, 2024 | Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson... | Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jan 9, 2024 | Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL | Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jan 9, 2024 | Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft an... | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... | Class II | Silex Medical, LLC |
| Jan 9, 2024 | Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft ... | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... | Class II | Silex Medical, LLC |
| Jan 9, 2024 | Custodiol HTK Solution, 500ml bottle. 10 per carton. | Potential for particles to be present in solution. | Class II | Dr Franz Koehler Chemie Gmbh |
| Jan 9, 2024 | Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC | manufacturing defects to sensor cable connectors may result in error codes or non-functioning c... | Class II | Covidien |
| Jan 9, 2024 | Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft a... | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... | Class II | Silex Medical, LLC |
| Jan 9, 2024 | DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparos... | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Aesculap Inc |
| Jan 9, 2024 | Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and M... | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... | Class II | Silex Medical, LLC |
| Jan 9, 2024 | DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparos... | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Aesculap Inc |
| Jan 9, 2024 | Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis | Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jan 9, 2024 | Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft an... | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... | Class II | Silex Medical, 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.