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 1041–1060 of 38,428 recalls
Recalled Item: BD Pyxis Pro MedStation Main
The Issue: fluid ingress of anesthesia station or med
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various models of BD Pyxis MedFlex
The Issue: fluid ingress of anesthesia station or med
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various models of BD Pyxis Pro 7-Drawer Auxiliary
The Issue: fluid ingress of anesthesia station or med
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMRIS Operating Suite
The Issue: There is a potential safety issue associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMRIS Operating Suite
The Issue: There is a potential safety issue associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: All Serial Numbers/BD Pyxis CII Safe ES Tower Main
The Issue: fluid ingress of anesthesia station or med
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various models of BD Pyxis Medbank: numbers: 1137-00 1145-00
The Issue: fluid ingress of anesthesia station or med
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR
The Issue: The potential for micro-air bubbles observed in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zenition 50
The Issue: Over time some systems may experience loss of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AART Calf Implant Product Name: Calf Implant Model/Catalog
The Issue: Due to manufactured products that deviated from established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AART Malar Implant Product Name: Malar Implant Model/Catalog
The Issue: Due to manufactured products that deviated from established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AART Silicone Carving Implant Product Name: Silicone Carving
The Issue: Due to manufactured products that deviated from established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AART Chin Implant Product Name: Chin Implant Model/Catalog
The Issue: Due to manufactured products that deviated from established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog
The Issue: Due to manufactured products that deviated from established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog
The Issue: Due to manufactured products that deviated from established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries
The Issue: Due to products manufactured under an inadequate quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SAFE-T-FILL Micro Capillary Blood Collection
The Issue: Due to products manufactured under an inadequate quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SAFE-T-FILL Micro Capillary Blood Collection
The Issue: Due to products manufactured under an inadequate quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SAFE-T-FILL MicroHematocrit Capillary Tubes
The Issue: Due to products manufactured under an inadequate quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SAFE-T-FILL Micro Capillary Blood Collection
The Issue: Due to products manufactured under an inadequate quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.