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 13741–13760 of 38,428 recalls
Recalled Item: Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product
The Issue: Speakers on IntelliVue X2 and IntelliVue MP2 may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lotus Edge Valve System
The Issue: Failure to execute the visual inspection correctly prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lotus Edge Valve System
The Issue: Failure to execute the visual inspection correctly prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lotus Edge Valve System
The Issue: Failure to execute the visual inspection correctly prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lotus Edge Valve System
The Issue: Failure to execute the visual inspection correctly prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lotus Edge Valve System
The Issue: Failure to execute the visual inspection correctly prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lotus Edge Valve System
The Issue: Failure to execute the visual inspection correctly prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tempus LS - Manual Defibrillator
The Issue: A software error was detected within software version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System
The Issue: Zimmer Biomet is conducting a medical device correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Contour VL Variable Length Ureteral Stent Set
The Issue: Trace amounts of metallic debris were found on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Contour VL Variable Length Ureteral Stent
The Issue: Trace amounts of metallic debris were found on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centeze Centesis Catheter
The Issue: Due to a manufacturing issue, the catheter tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Capnostream 35 Portable Respiratory Monitor
The Issue: The firm has released software update V01.05.02.16 (also
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Cobalt DR MRI SureScan DDPB3D1
The Issue: Under rare circumstances, the component may be susceptible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1
The Issue: Under rare circumstances, the component may be susceptible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic COBALT HF QUAD CRT-D MRI SureScan
The Issue: Under rare circumstances, the component may be susceptible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable...
The Issue: There is potential for fractures which results in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thyroid Pack CKHA-LF
The Issue: The cylindrical sponge component is not x-ray detectable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Resect. Intest. Laparo-LF
The Issue: The cylindrical sponge component is not x-ray detectable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiac Pack - LF
The Issue: The cylindrical sponge component is not x-ray detectable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.