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 14061–14080 of 38,428 recalls
Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene
The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene
The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene
The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene
The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene
The Issue: Sterilant (hydrogen peroxide) used in acetabular cup hip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Streamline TL Navigation System
The Issue: The Streamline Navigation System taps have experienced binding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Streamline MIS Navigation System Taps
The Issue: The Streamline Navigation System taps have experienced binding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Yuno Mobile Operating Table - Product Usage: Intended for support
The Issue: Plastic socket of the IEC 60320-1 socket pulled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Yuno II Mobile Operating Table - Product Usage: support and
The Issue: Plastic socket of the IEC 60320-1 socket pulled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProVu Single Use Video Stylet with ET Tube
The Issue: When the video stylet cuff is over-inflated there
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kangaroo Connect 1000ml Bag Set
The Issue: The feeding spike sets may leak at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kangaroo Connect 500ml Bag Set
The Issue: The feeding spike sets may leak at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA
The Issue: There is potential when a user changes an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TroClose 1200 - Product Usage: intended for use in a variety of gynecologic
The Issue: Endotoxin test results found above the acceptable levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal)
The Issue: There is an intermittent software issue that could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP)
The Issue: Incorrectly installed base
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 9310HD Digital Video Capture Module with software version 3.4.0 or
The Issue: There is an intermittent software issue that could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the
The Issue: Fructosamine QC and patient samples may exhibit a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in
The Issue: Fructosamine QC and patient samples may exhibit a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iTotal Hip Replacement System
The Issue: Incorrect hip components were provided in kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.