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 13061–13080 of 38,428 recalls
Recalled Item: Interventional Fluoroscopic X-Ray System - Product Usage: developed for single
The Issue: Siemens has become aware of a potential issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biosense Webster
The Issue: There is a potential for the hemostatic valve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAIRE DIAGNOSTICS FenomPro SN ***** - Product Usage: a portable
The Issue: Erroneously high FeNO levels which may contribute to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided
The Issue: The set screws that connect the Standard Treatment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Infusion Pump Module
The Issue: Bezel repair parts used, not by the original
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in...
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amicus Exchange Kit - Product Usage: intended for use in
The Issue: Some lots of Amicus MNC Apheresis and Amicus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amicus MNC Apheresis Kit - Double Needle - Product Usage:
The Issue: Some lots of Amicus MNC Apheresis and Amicus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Infusion Pump 8100 Bezel (plastic piece only)
The Issue: Bezel repair parts used, not by the original
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amicus Exchange Kit Therapeutics - Product Usage: intended for use
The Issue: Some lots of Amicus MNC Apheresis and Amicus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Infusion Pump Module
The Issue: Bezel repair parts used, not by the original
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOCARE Medical
The Issue: Their is a potential that the automated staining
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: In-View Clear Leggings Sterile
The Issue: Cardinal Health has determined that a manufacturing variance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: In-View Clear Leggings Sterile Non-Sterile
The Issue: Cardinal Health has determined that a manufacturing variance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Femoral Angiography Drape Bulk Non-Sterile
The Issue: Cardinal Health has determined that a manufacturing variance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Femoral Angiography Drape Sterile
The Issue: Cardinal Health has determined that a manufacturing variance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: In-View Clear Leggings Bulk Non-Sterile
The Issue: Cardinal Health has determined that a manufacturing variance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142
The Issue: Scalpel and StatLock components packaged with specific lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KWIK-STIK
The Issue: of products packaged for lot 323-108-7 were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KWIK-STIK
The Issue: that products packaged for lot 726-57-10 were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.