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 12461–12480 of 38,428 recalls
Recalled Item: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option
The Issue: Significant wear of the Monitor Bracket Assembly shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option
The Issue: Significant wear of the Monitor Bracket Assembly shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option
The Issue: Significant wear of the Monitor Bracket Assembly shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option
The Issue: Significant wear of the Monitor Bracket Assembly shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option
The Issue: Significant wear of the Monitor Bracket Assembly shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option
The Issue: Significant wear of the Monitor Bracket Assembly shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option
The Issue: Significant wear of the Monitor Bracket Assembly shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option
The Issue: Significant wear of the Monitor Bracket Assembly shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hang&Go (kit for hyperthermic perfusion)
The Issue: The sterilization contractor informed the company of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ch24 round silicone catheter
The Issue: The sterilization contractor informed the company of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACE Control Set - IVD Control set for the quantitative
The Issue: Claim for stability after reconstitution from lyophilized to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Myriad-LX Light Source-for delivery of light to the surgical field
The Issue: (1) Updated IFU for the LX Illumination Packs:
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131.
The Issue: The affected Wallach LOOP Electrodes were incorrectly packaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Tissue Recovery Instrument Set
The Issue: The devices may not meet the minimum required
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WishBone Medical Plate and Screw System - Screw
The Issue: Nonconformities were discovered to the engineering specifications for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NICO Myriad-LX Illumination Pack: Mvriad-LX Illumination Pack. 11ga
The Issue: (1) Updated IFU for the LX Illumination Packs:
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The
The Issue: Software versions 6.0.4 to 6.2.1 using Advanced Reporting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hays Ultrasound kit Item ID: H1000SE
The Issue: No 510k for the product to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Probe Cover
The Issue: No 510k for the product to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6" x 48" Elastic Poly Probe Cover
The Issue: No 510k for the product to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.