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 24521–24540 of 38,428 recalls
Recalled Item: Rotational Intravascular Ultrasound (IVUS) Catheter
The Issue: High complaint rates of kinking near the junction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE426R
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GP321R
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GP161R
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MR GHIATAS Beaded Breast Localization Wire
The Issue: It may be at risk of containing a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 216 Wilson Frame Pads
The Issue: Mizuho has discovered that the 5319-37 Wilson Frame
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee
The Issue: Software error - As a result of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Delta
The Issue: It was reported that a set low O2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Delta XL
The Issue: It was reported that a set low O2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kappa
The Issue: It was reported that a set low O2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant
The Issue: Missing Dome Pack accessory
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Patient Care Kits Product Usage: A Patient Care Kit
The Issue: Alcon is initiating a Voluntary Medical Device Removal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Craftmatic Model 1 Base for Dual Bed Configurations
The Issue: A potential for dual-configured beds to separate or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Legacy Base for Dual Bed Configurations
The Issue: A potential for dual-configured beds to separate or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WECK Visistat 35R Disposable Skin Stapler
The Issue: Some boxes are labeled as containing Visistat Wide
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anthrex Bio-SwiveLock SP Vented
The Issue: Some eyelets broke from SwiveLock Anchor on insertion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented
The Issue: Some eyelets broke from SwiveLock Anchor on insertion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anthrex PEEK SwiveLock SP Vented
The Issue: Some eyelets broke from SwiveLock Anchor on insertion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anthrex PEEK SwiveLock SP Vented
The Issue: Some eyelets broke from SwiveLock Anchor on insertion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anthrex Bio Composite SwiveLock SP Vented
The Issue: Some eyelets broke from SwiveLock Anchor on insertion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.