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 101–120 of 38,428 recalls
Recalled Item: FDR Visionary Suite
The Issue: It was found that the contacts of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bubble Sensor for 3/8" x 3/32" tubing
The Issue: Internal investigations have identified an issue with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name:
The Issue: Mis-wired component-the improperly wired component can result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU
The Issue: Affected lots may exhibit issues with the silicone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU
The Issue: Affected lots may exhibit issues with the silicone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Convenience kits used for dialysis maintenance Medline ADD A CATH
The Issue: Affected lots may exhibit issues with the silicone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Kits containing Tego Connectors: Medline IR Pack
The Issue: Affected lots may exhibit issues with the silicone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING...
The Issue: Affected lots may exhibit issues with the silicone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT
The Issue: Affected lots may exhibit issues with the silicone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST
The Issue: Medline has identified issues related to calibration of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION
The Issue: Medline has identified issues related to calibration of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience Kits: 1) KIT ACES INSERT PEG
The Issue: Medline has identified issues related to calibration of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience Kits: 1) DRAPE PACK-CHOICE
The Issue: Medline has identified issues related to calibration of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience Kits: 1) LVAD DRIVELINE TRAY
The Issue: Medline has identified issues related to calibration of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience Kits: 1) ADMIT KIT
The Issue: Medline has identified issues related to calibration of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS
The Issue: Medline has identified issues related to calibration of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS
The Issue: Medline has identified issues related to calibration of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience Kits: 1) KIT GENERAL CLOSURE
The Issue: Medline has identified issues related to calibration of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY
The Issue: Medline has identified issues related to calibration of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS
The Issue: Medline has identified issues related to calibration of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.