Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 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 |
| 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 | 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 | Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC | manufacturing defects to sensor cable connectors may result in error codes or non-functioning c... | Class II | Covidien |
| Jan 9, 2024 | Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST" | 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 | DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic pr... | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Aesculap Inc |
| 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 | 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 | 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 | 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.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, 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 | 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 | 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, 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 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, 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 | 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 | 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 | 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 | 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 8, 2024 | BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susce... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro su... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro su... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro sus... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quanti... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for ... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro sus... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro suscep... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. | The negative control was contaminated with one of the positive control pathogens (Norovirus). Th... | Class II | Microbiologics Inc |
| Jan 8, 2024 | BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susce... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susc... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro su... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susc... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susce... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro su... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro sus... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro suscep... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro sus... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 70... | Nonconformities at their seal could potentially compromise the sterile barrier for affected produ... | Class II | Maquet Medical Systems USA |
| Jan 8, 2024 | BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Ca... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susc... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro sus... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 70... | Nonconformities at their seal could potentially compromise the sterile barrier for affected produ... | Class II | Maquet Medical Systems USA |
| Jan 8, 2024 | BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susce... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g, Catalog Number 231660... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
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.