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 32141–32160 of 38,428 recalls
Recalled Item: Surgeon Reinforced Gown XL
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laparoscopy Chole Pack
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laparotomy Surgical Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Extremity PACK
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wound Management Tray Ryder Memorial
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C-Section Surgical Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liposuction Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cataract Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wound Management Tray Ill
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Vent Catheters
The Issue: Edwards Lifesciences is conducting a field action on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is
The Issue: The patient record peel-off label product code and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker SmartLife Large Aseptic Housing Rx Only The
The Issue: The SmartLife Aseptic Housings are being recalled in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker SmartLife Small Aseptic Housing Rx Only The
The Issue: The SmartLife Aseptic Housings are being recalled in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Box Label: 3 mm Cueva Electrode Kit
The Issue: The recall has been initiated due to concerns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RESTORIS PST Straight Shell Inserter An impactor is a reusable
The Issue: MAKO has identified the potential that the shell
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RESTORIS PST Acetabular Offset Shell Impactors An impactor is a
The Issue: MAKO has identified the potential that the shell
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RESTORIS PST Acetabular Straight Shell Impactors An impactor is a
The Issue: MAKO has identified the potential that the shell
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone
The Issue: The product is non-sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Persona Tibial Articular Surface Inserter is a sterilizable instrument
The Issue: Affected product did not undergo heat treatment hardening
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage:
The Issue: Martara Instrument, Inc. has recently became aware of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.