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 1801–1820 of 38,428 recalls
Recalled Item: Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10
The Issue: for temporary loss of imaging (X-ray) functionality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartSine SAM 350P
The Issue: Due to a component manufacturing issue, Automated External
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Ambition X Model Numbers (REF): (1) 781356
The Issue: The potential for component failures in the Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laser light show projectors manufactured by BLS
The Issue: The remote interlock connector, which is required by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laser light show projectors manufactured by BLS
The Issue: The remote interlock connector, which is required by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laser light show projectors manufactured by BLS
The Issue: The remote interlock connector, which is required by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold
The Issue: Device does not comply with the labeling requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LYFO-DISK
The Issue: KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Injection needle
The Issue: Affected product show elevated cytotoxicity values. Use of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LYFO-DISK
The Issue: KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation
The Issue: for false resistant results for Colistin (cs02n)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UIBC (Unsaturated Iron Binding Capacity)
The Issue: Beckman Coulter identified that the Unsaturated Iron Binding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
The Issue: Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Breathing circuit set
The Issue: Ventilator coaxial breathing circuit may have a crack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base
The Issue: Engaging titanium base was manufactured 180 degrees around
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FARAWAVE 1.0 Pulsed Field Ablation Catheter
The Issue: The potentially impacted units were manufactured using specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxI 800 Access Immunoassay Analyzer W/Dual Gantry
The Issue: Beckman Coulter has identified that the UniCel DxI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxI 600 Access Immunoassay Analyzer W/Spot B
The Issue: Beckman Coulter has identified that the UniCel DxI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxI 800 Access Immunoassay Analyzer W/Spot B
The Issue: Beckman Coulter has identified that the UniCel DxI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxI 600 Access Immunoassay Analyzer W/Dual Gantry
The Issue: Beckman Coulter has identified that the UniCel DxI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.