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 2701–2720 of 38,428 recalls
Recalled Item: Microstream Instructions for Use and Part Number used with - Product Description
The Issue: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Na
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microstream Instructions for Use and Part Number used with - Product Description
The Issue: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Na
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microstream Instructions for Use and Part Number used with - Product Description
The Issue: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Na
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in.
The Issue: Increased risk for valve housing detachment causing leakage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microstream Instructions for Use and Part Number used with - Product Description
The Issue: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Na
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aveir DR Leadless Pacemaker (LP) Ventricular Device UDI-DI
The Issue: Due to a manufacturing issue, leadless pacemakers may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Modular Stem cylindrical
The Issue: A problem was discovered during the scanning process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAPNOCHECK BCI Airway Adapter
The Issue: Airway adapter does not meet specification and may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Modular Stem cylindrical
The Issue: A problem was discovered during the scanning process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAPNOCHECK BCI Airway Adapter
The Issue: Airway adapter does not meet specification and may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Modular Stem cylindrical
The Issue: A problem was discovered during the scanning process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical ProPort Plastic Venous Access System
The Issue: The plastic port housing and port reservoir of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical ProPort Plastic Venous Access System
The Issue: The plastic port housing and port reservoir of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proxima Drape labeled as PACK
The Issue: breach in pouch packaging which could lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical ProPort Plastic Venous Access System
The Issue: The plastic port housing and port reservoir of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical ProPort Low Profile Plastic Venous Access System
The Issue: The plastic port housing and port reservoir of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proxima Drape labeled as ORTHO TRAUMA CDS
The Issue: breach in pouch packaging which could lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical ProPort Plastic Venous Access System
The Issue: The plastic port housing and port reservoir of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical ProPort Plastic Venous Access System
The Issue: The plastic port housing and port reservoir of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
The Issue: breach in pouch packaging which could lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.