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 1861–1880 of 38,428 recalls
Recalled Item: Baxter SIGMA Spectrum Infusion Pump V6
The Issue: Certain Spectrum infusion pumps may have an incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter SIGMA Spectrum Infusion Pump V8
The Issue: Certain Spectrum infusion pumps may have an incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinia
The Issue: Unintended radial detector motion may occur during patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Varicam
The Issue: Unintended radial detector motion may occur during patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portable X-ray system
The Issue: Some DIOX-602 units currently in use within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tubing for Male Connector 194
The Issue: Discrepancies between sterilization instructions in the Japanese language
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated...
The Issue: Foley catheter may have an obstructed lumen, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic CareLink SmartSync Patient Connector
The Issue: In prior SmartSync application versions, the Abort button
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker
The Issue: Due to complaints their is the potential that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter
The Issue: Discrepancies between sterilization instructions in the Japanese language
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic CareLink SmartSync Device Manager
The Issue: In prior SmartSync application versions, the Abort button
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cone with Male Tubing
The Issue: Discrepancies between sterilization instructions in the Japanese language
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natus Brain Monitor Breakout Box
The Issue: Natus received two complaints of left side labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glass Body For 194 Ellik Evacuator. Model Number: 190A. The
The Issue: Discrepancies between sterilization instructions in the Japanese language
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ellik Latex Bulb
The Issue: Discrepancies between sterilization instructions in the Japanese language
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ellik Evacuator Adapter
The Issue: Discrepancies between sterilization instructions in the Japanese language
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Green Silicone Seal for Accessories
The Issue: Discrepancies between sterilization instructions in the Japanese language
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker
The Issue: Due to complaints their is the potential that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blue Silicone
The Issue: Discrepancies between sterilization instructions in the Japanese language
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.