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 26741–26760 of 38,428 recalls
Recalled Item: Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is...
The Issue: Arrow is recalling due to incorrect labeling of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T2Candida¿Cartridges
The Issue: Elevated levels of invalid results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UNIQ 1.0: UNIQ FD10
The Issue: Increase in the failure rate of certain low-voltage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper with release R8.2: Allura Xper FD10
The Issue: Increase in the failure rate of certain low-voltage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/ zeego
The Issue: Due to an error in the 19 Live
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard TruGuide Disposable Coaxial Biopsy Needle Mixed Product Part
The Issue: May contain two trocar tip stylets with coaxials
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EnVision FLEX+
The Issue: The pH of Target Retrieval Solution in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPHERICAL HEAD (R) 6.5 MM CANCELLOUS SCREW
The Issue: The labels correctly state that the product should
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optilite Freelite Lambda Free Kit Product Code: LK018.OPT
The Issue: Batch numbers listed are reporting Lambda Free Light
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit
The Issue: Some v2.2.2 upgrade kits include a dialysate mode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AmediCheck Instant Test Cup
The Issue: Branan Medical is recalling the AmediCheck Instant Test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RePlant¿ Angled Abutment Part Number 6050-52-60
The Issue: Issue with design specification; oversized condition
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer¿ Air Dermatome II Handpiece Loaner
The Issue: Zimmer Biomet Surgical has received product complaints reporting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer¿ Air Dermatome II Width Plate
The Issue: The surface coating applied to the device is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer¿ Air Dermatome II Handpiece w/o Hose
The Issue: The surface coating applied to the device is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer¿ Air Dermatome II Width Plate
The Issue: The surface coating applied to the device is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer¿ Air Dermatome II Width Plate
The Issue: The surface coating applied to the device is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer¿ Air Dermatome II Handpiece
The Issue: The surface coating applied to the device is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer¿ Air Dermatome II Width Plate
The Issue: The surface coating applied to the device is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer¿ Air Dermatome II Width Plate
The Issue: The surface coating applied to the device is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.