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 32181–32200 of 38,428 recalls
Recalled Item: Specialty Audible Torque Wrench Mfg by: Stryker Spine
The Issue: Stryker has received a complaint from customers relating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur BNP Assay for in vitro diagnostic use in
The Issue: Siemens Healthcare Diagnostics has confirmed that approximately 2000
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric...
The Issue: Non-injury complaints from Europe identified a malfunction that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access 2 Immunoassay Systems
The Issue: Beckman Coulter is recalling the Small Form Factor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxC 600i SYNCHRON Access Clinical Analyzer
The Issue: Beckman Coulter is recalling the Small Form Factor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laksell Gamma Knife Perfexion
The Issue: Elekta has become aware that the latches may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SideFire Directional Laser Probe
The Issue: Monteris Medical received a complaint of a separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FullFire Diffusing Tip Laser Probe
The Issue: Monteris Medical received a complaint of a separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital
The Issue: GE Healthcare initiated a field correction because prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Series OEC 9800. The Series OEC 9800 is designed to
The Issue: GE Healthcare initiated a field correction because prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC¿ UroView 2800. The UroView 2800 is designed to provide
The Issue: GE Healthcare initiated a field correction because prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is
The Issue: GE Healthcare initiated a field correction because prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips IntelliVue Monitors with software revisions J.21.03
The Issue: Philips Intellivue and Avalon Fetal Monitors in time-synchronized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Avalon Monitors with software revision J.30.58: Model Product FM20
The Issue: Philips Intellivue and Avalon Fetal Monitors in time-synchronized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natural Knee II Revision Femoral Stem
The Issue: Failed to meet established requirements for sterile barrier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes Radiolucent Retractor
The Issue: Particle residue on the instrument from adhesive tape
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Puritan Bennett 980 Ventilator
The Issue: Covidien is recalling certain Puritan Bennett 980 Ventilator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transport Rollator with Padded Seat
The Issue: The caster may separate completely from the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Puritan Bennett 980 Ventilator
The Issue: A software issue may lead to ventilator inoperative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tapered Screw-Vent Implant
The Issue: Zimmer Dental is recalling Tapered Screw-Vent Implants because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.