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 6581–6600 of 38,428 recalls
Recalled Item: Custom procedural convenience kits and trays
The Issue: During an internal investigation, ACS identified that several
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom procedural convenience kits and trays
The Issue: During an internal investigation, ACS identified that several
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom procedural convenience kits and trays
The Issue: During an internal investigation, ACS identified that several
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom procedural convenience kits and trays
The Issue: During an internal investigation, ACS identified that several
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom procedural convenience kits and trays
The Issue: During an internal investigation, ACS identified that several
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom procedural convenience kits and trays
The Issue: During an internal investigation, ACS identified that several
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom procedural convenience kits and trays
The Issue: During an internal investigation, ACS identified that several
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensis Vibe Hemo
The Issue: The possibility of the Sensis documentation functionality application
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown)
The Issue: Surgical gowns were manufactured with the wrong sleeve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ivenix Infusion System (IIS)
The Issue: The device may experience mechanical interference on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MICRO-X Rover Mobile X-ray System
The Issue: Mobile x-ray system can report and deliver a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cortera Spinal Fixation System
The Issue: Spinal fixation screws labeled as 8.5 mm diameter,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Packaged
The Issue: AtriCure has identified certain lots of tank hose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cryo Module Accessories Domestic CMA-OUS
The Issue: AtriCure has identified certain lots of tank hose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volar Bearing Plate.
The Issue: Plates, part of a wrist fixation system, are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Patient Information Center iX
The Issue: Push notifications may fail to send to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) CareEvent
The Issue: Push notifications may fail to send to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Scoot Control R-net
The Issue: In rare cases, the lever of the throttle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VADER pedicle system
The Issue: icotec has received notification of one revision that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic
The Issue: Their is the potential that the percutaneous pin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.