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 881–900 of 38,428 recalls
Recalled Item: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s
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: Patient Monitor Model/Catalog Number: X8
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: Fetal & Maternal Monitor Model/Catalog
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: iM50
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: iM20
The Issue: As a result of receiving an FDA It
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Senographe Pristina
The Issue: Some Senographe Pristina systems either have a missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAMMOMAT Inspiration
The Issue: There were instances where the operator table was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAMMOMAT Fusion
The Issue: There were instances where the operator table was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAMMOMAT Revelation
The Issue: There were instances where the operator table was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue
The Issue: The IFU addendum updates the Vibration and Shock
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid
The Issue: The IFU addendum updates the Vibration and Shock
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Kiestra" Isolate Suspension Cuvette Array
The Issue: The 2D barcodes on these cuvettes contain formatting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Thunderbeat 5 mm
The Issue: Firm is initiating a removal due to continued
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Thunderbeat
The Issue: Firm is initiating a removal due to continued
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Thunderbeat 5 mm
The Issue: Firm is initiating a removal due to continued
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Thunderbeat
The Issue: Firm is initiating a removal due to continued
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Thunderbeat 5 mm
The Issue: Firm is initiating a removal due to continued
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Thunderbeat
The Issue: Firm is initiating a removal due to continued
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Thunderbeat 5 mm
The Issue: Firm is initiating a removal due to continued
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.