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 23081–23100 of 38,428 recalls
Recalled Item: Spectranetics Bridge Occlusion Balloon catheter
The Issue: inability to pass the guidewire through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm
The Issue: Software discrepancy of not showing all the EE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Hip Application (THA) Product Usage: The Robotic Arm Interactive
The Issue: Software discrepancy of not showing all the EE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating
The Issue: There is a potential for the hydrophilic coating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OneStep CPR Complete
The Issue: A portion of one lot of ZOLL OneStep
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fuji Computed Radiography Mammography Suite
The Issue: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System
The Issue: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aspire HD Plus
The Issue: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System
The Issue: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultradent Products
The Issue: The barcode label was placed underneath the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultradent Products
The Issue: The barcode label was placed underneath the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultradent Products
The Issue: The barcode label was placed underneath the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultradent Products
The Issue: The barcode label was placed underneath the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultradent Products
The Issue: The barcode label was placed underneath the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MODIFIED/SPECIAL INSTRUMENT
The Issue: It was reported that the models used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
The Issue: "Chattering" when cutting burrs are used in bone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heliomolar 20x0.25g 110/A1
The Issue: Complaints were filed claiming the material consistency was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heliomolar 20x0.25g 140/A2
The Issue: Complaints were filed claiming the material consistency was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heliomolar 20x0.25g 110T
The Issue: Complaints were filed claiming the material consistency was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heliomolar 20x0.25g 210/A3
The Issue: Complaints were filed claiming the material consistency was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.