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 11881–11900 of 38,428 recalls
Recalled Item: Zoll (IC-3893)
The Issue: Labeling update concerning potential leaks from the catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zoll (IC-4593AE)
The Issue: Labeling update concerning potential leaks from the catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zoll (IC-4593CO)
The Issue: Labeling update concerning potential leaks from the catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zoll (IC-4593)
The Issue: Labeling update concerning potential leaks from the catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zoll
The Issue: Labeling update concerning potential leaks from the catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NAMIC Stopcocks: (1) NAMIC STOPCOCK
The Issue: for sterile barrier breach. Microscopic pinholes within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD
The Issue: for sterile barrier breach. Microscopic pinholes within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is
The Issue: Image acquisition failures and synchronization failure with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity PACS-IW with Universal Viewer - Product Usage: Is a
The Issue: Image acquisition failures and synchronization failure with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0
The Issue: Due to a software defect that can intermittently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0
The Issue: Due to a software defect that can intermittently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NORMOFLO Irrigation Warming administration set (disposable)
The Issue: There is potential for harmful levels of aluminum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic HVAD Pump Implant Kits
The Issue: There is more force required to slide the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
The Issue: There is potential for harmful levels of aluminum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A319416AM
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A800360
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A899916
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A902616
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Soft Tissue Biopsy Needles
The Issue: Sterility assurance may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mammary Nodules Localization
The Issue: Sterility assurance may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.