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 32521–32540 of 38,428 recalls
Recalled Item: CLAW II 2 HOLE PLATE ORTHOLOC 3DSi
The Issue: Plates manufactured from an incorrect raw material
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM
The Issue: Plates manufactured from an incorrect raw material
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Container Lid
The Issue: Integra LifeSciences has identified through an internal investigation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLAW II STRAIGHT PLATE ORTHOLOC 3DSi
The Issue: Plates manufactured from an incorrect raw material
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLAW II STRAIGHT PLATE ORTHOLOC 3DSi
The Issue: Plates manufactured from an incorrect raw material
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral...
The Issue: Internal review found that five (5) PFJ implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer PERSONA Distal Valgus Alignment Guide
The Issue: Persona Distal Valgus Alignment guide collet locks are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead).
The Issue: The Directions for Use (DFU) manual contains information
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead).
The Issue: The Directions for Use (DFU) manual contains information
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Symbia T Series consists of the T16
The Issue: Siemens Medical Solutions USA, Inc. is performing a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Symbia Intevo series consists of the Intevo 16
The Issue: Siemens Medical Solutions USA, Inc. is performing a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Minstrel (with scale) Product Usage: is a mobile passive hoist.
The Issue: ArjoHuntleigh received three reports where the bolt under
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen
The Issue: These lots of Agar may have exhibited breakthrough
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Illumina Worklist Manager (IWM) (software v1.0.15)
The Issue: A software component of the MiSeqDx instrument, called
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RADIANCE v. 2.4X Recalled by Radiometer America Inc Due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliSpace Portal (ISP) DX/HX/EX
The Issue: The following software issues have been identified in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery
The Issue: Estill has discovered that a fully discharged Ultra
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 0.9% Sodium Chloride Injection
The Issue: Unit packages may exhibit open seals which impacts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SUN DASH RADIUS 252 PN 8000809705. The device is intended
The Issue: The integrity of the wires inside main electrical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL Sleeve Installation Tool Sizes: 6mm
The Issue: Weld fractures on the Sleeve Installation Tool for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.