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 861–880 of 38,428 recalls
Recalled Item: Quick Strip Fabric Sterile Adhesive Bandages
The Issue: Medline has identified that all lots of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20.
The Issue: Between July 2024 and June 2025, Philips Azurion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quick Strip Plastic Sterile Adhesive Bandages
The Issue: Medline has identified that all lots of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fur Friends Plastic Sterile Adhesive Bandages
The Issue: Medline has identified that all lots of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CURAD Germ-Shield Touch-Free Fabric Bandages
The Issue: Medline has identified that all lots of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Curad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4" x 3"
The Issue: Medline has identified that all lots of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE PERFUSION SYRINGE
The Issue: Medline Industries, LP is issuing a recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemodialysis System
The Issue: Screw may loosen or fallout of Hemodialysis system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quick Strip Plastic Sterile Adhesive Bandages
The Issue: Medline has identified that all lots of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5008X CAREsystem +CLiC +CDX
The Issue: Several software anomalies with the potential to impact
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2
The Issue: As a result of receiving an FDA It
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EDAN Product Name: Vital Signs Monitor Model/Catalog Number:
The Issue: As a result of receiving an FDA It
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EDAN Product Name: Central Monitoring System Model/Catalog Number:
The Issue: As a result of receiving an FDA It
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EDAN Product Name: Vital Signs Monitor Model/Catalog Number:
The Issue: As a result of receiving an FDA It
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20
The Issue: As a result of receiving an FDA It
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10
The Issue: As a result of receiving an FDA It
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5
The Issue: As a result of receiving an FDA It
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8
The Issue: As a result of receiving an FDA It
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EDAN Product Name: Vital Signs Monitor Model/Catalog Number:
The Issue: As a result of receiving an FDA It
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EDAN Product Name: Vital Signs Monitor Model/Catalog Number:
The Issue: As a result of receiving an FDA It
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.