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 4521–4540 of 38,428 recalls
Recalled Item: Beckman Coulter DxI 9000 Access Immunoassay Analyzer
The Issue: Beckman Coulter is recalling the DxI 9000 Access
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guidewire 70cm x 1mm (0.038 ) These accessories
The Issue: Due to guidewires being manufactured incorrectly with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxC 500 AU Clinical Chemistry Analyzer
The Issue: Due to a software issues, after the instrument
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IBA Proton Therapy System - PROTEUS 235- Designed to produce
The Issue: Temporary deactivation of collision detection for Forte Robotic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The VITROS XT Chemistry Products ALB-TP Slides is a single
The Issue: The reason for this recall is QuidelOrtho has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DIAMOND POINT
The Issue: Smith & Nephew, Inc., has initiated a field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DIAMOND POINT
The Issue: Smith & Nephew, Inc., has initiated a field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic DLP Single Stage Venous Cannulae with right angle metal tip
The Issue: During manufacturing, DLP Single Stage Venous Cannulae -
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BKIT BD Pyxis QFill Replenishment Station
The Issue: Due to software issue, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis QFill Replenishment Station
The Issue: Due to software issue, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McGrath Mac Video Laryngoscope
The Issue: Battery management system within Laryngoscope devices may deplete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covideien McGRATH MAC Video Laryngoscope
The Issue: IFU update to address device's battery handling information
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McGRATH" MAC EMS Video Laryngoscope
The Issue: Battery management system within Laryngoscope devices may deplete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aurora 4 Series
The Issue: The weld on the light head frame can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aurora Series
The Issue: The weld on the light head frame can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aurora 3 Series
The Issue: The weld on the light head frame can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aurora 2 Series
The Issue: The weld on the light head frame can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution
The Issue: There is a potential risk that the image
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TruDi NAV Suction
The Issue: Specific lots of TruDi NAV Suction Instruments 0
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE
The Issue: Safety Parameters Verification Mechanisms can be deactivated in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.