Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 3701–3720 of 38,428 recalls
Recalled Item: AMBU / KING LTSD
The Issue: Exceed the limitations to the 510 (k) exemption
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KING LTSD
The Issue: Exceed the limitations to the 510 (k) exemption
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KING LTSD
The Issue: Exceed the limitations to the 510 (k) exemption
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KING LTSD
The Issue: Exceed the limitations to the 510 (k) exemption
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Duraform Dural Graft Implant
The Issue: Out of specification endotoxin levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KING LTSD
The Issue: Exceed the limitations to the 510 (k) exemption
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KING LTSD
The Issue: Exceed the limitations to the 510 (k) exemption
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KING LTSD
The Issue: Exceed the limitations to the 510 (k) exemption
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KING LTSD
The Issue: Exceed the limitations to the 510 (k) exemption
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack
The Issue: Certain lots of listed lots of Cardinal Health
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT
The Issue: Complaints were received regarding needle pull-off and suture
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System
The Issue: Elekta has become aware that Disposable Biopsy Needles
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: intelliPATH Universal HRP Detection Kit
The Issue: Kits containing the DAB chromogen buffer, intended for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Retrospective; Their is the potential that implantable intramedullary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: medex TranStar Single OR Set 1/EA
The Issue: Due to a manufacturing defect, users may experience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: medex TranStar 72in (183cm) Double Monitoring Kit 10/EA
The Issue: Due to a manufacturing defect, users may experience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: medex TranStar Neonatal Monitoring Kit 10/EA
The Issue: Due to a manufacturing defect, users may experience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System
The Issue: Siemens Healthcare Diagnostics Inc. has confirmed that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture
The Issue: Due to packaging damage from heat exposure during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029
The Issue: Does not meet the requirements for electromagnetic compatibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.