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 21701–21720 of 38,428 recalls
Recalled Item: FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System)...
The Issue: Recently Integrity Implants uncovered a discrepancy in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQURE
The Issue: There is a potential problem relating to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard(R) Premature Infant Feeding tube
The Issue: BMD has identified that the product code/lot number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard(R) Adult/Pediatric Feeding Tube
The Issue: BMD has identified that the product code/lot number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard(R) Infant Feeding Tube
The Issue: BMD has identified that the product code/lot number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard(R) Premature Infant Feeding Tube
The Issue: BMD has identified that the product code/lot number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO )
The Issue: It was discovered that the laser energy was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sternal Valve Retractors With Atrial and Aortic Rakes
The Issue: Failure in a retractor blade due to corrosion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MindFrame Capture LP Revascularization Devices: Product Numbers: (a)
The Issue: There is a potential issue for all MindFrame
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wet-Field Hemostatic Eraser Bipolar 25G
The Issue: Products were packaged with incorrect labeling,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Analyzer and Atellica IM 1600 Analyzer system for in vitro
The Issue: When more than one immunoassay analyzer is connected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica Solution and Atellica Sample Handler Prime for in vitro
The Issue: When more than one immunoassay analyzer is connected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WET-FIELD OSHER THERMODOT MARKER
The Issue: Incorrect tip was used during manufacturing of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
The Issue: When more than one immunoassay analyzer is connected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cold Storage Solution
The Issue: Bags of solution may have a small leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or
The Issue: A cover failed leak testing during validation testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T4 Zipper Toga (S/M)
The Issue: Separation of material layers may occur, causing a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T4 Zipper Toga
The Issue: Separation of material layers may occur, causing a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T5 Zipper Toga with Peel-Away Face Shield
The Issue: Separation of material layers may occur, causing a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T4 Pullover Toga
The Issue: Separation of material layers may occur, causing a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.