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 6101–6120 of 38,428 recalls
Recalled Item: VITROS XT 3400 Chemistry System
The Issue: A software defect affecting VITROS Systems running VITROS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IdentiTi ALIF Standalone Interbody System: Part Number/Description...
The Issue: Due to reports of intraoperative graft bolt implantation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Schiff Reagent
The Issue: This IVD is colorless. A customer complaint was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit)...
The Issue: Due to potential signals of increased false positive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with:
The Issue: Due to a trend in false positive Candida
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sofsilk Braided Silk sutures
The Issue: One lot of product was exposed to more
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SW Bari Lift & Transfer
The Issue: Retrospective engineering analysis against current ISO standards for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ionolux
The Issue: Due to an error in the manufacturing process,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IonoStar Plus
The Issue: Due to an error in the manufacturing process,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: impression coping
The Issue: The depth of the internal canal was not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM Erythropoietin (EPO) Assay (100 Test)
The Issue: Siemens Healthcare Diagnostics has confirmed an average negative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
The Issue: Siemens Healthcare Diagnostics has confirmed an average negative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Opal
The Issue: Products not sterilized, sterility cannot be confirmed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RAPIDSORB IPS Battery Pack
The Issue: Products not sterilized, sterility cannot be confirmed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX
The Issue: Products not sterilized, sterility cannot be confirmed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TFNA Femoral Nail 9mm
The Issue: Products not sterilized, sterility cannot be confirmed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1.5MM Drill Bit/QC/85MM Sterile-surgical
The Issue: Products not sterilized, sterility cannot be confirmed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VA-LCP Clavicle Plate 2.7
The Issue: Products not sterilized, sterility cannot be confirmed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical
The Issue: Products not sterilized, sterility cannot be confirmed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RIA Tube Assembly
The Issue: Products not sterilized, sterility cannot be confirmed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.