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 34701–34720 of 38,428 recalls
Recalled Item: Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left...
The Issue: Product mix occurred prior to final package and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Vantage Digital Panoramic System delivers high-value features standard on
The Issue: An error was identified in the Real Time
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
The Issue: The trial insertion instrument may disassemble during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultima OPCAB System
The Issue: MAQUET has identified a potential issue with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aesculap Columbus Revision CoCr 15mm distal and posterior spacers
The Issue: The Columbus Revision CoCr 15 mm distal and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multi Absorber Original
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.)
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brand: The ForeCYTE Breast Health Test
The Issue: Atossa Genetics is recalling ForeCYTE Breast Health Test,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0)
The Issue: System downtime and/or slow performance may result if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method
The Issue: Dimension Vista HCYS lot 13064MA shows erratic recovery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Individual units labeled in part:
The Issue: Richard Wolf Medical Instrument Corporation recieved a complaint
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD 100NX Cassettes The STERRAD Sterilization System is a low
The Issue: Advanced Sterilization Products (ASP) is recalling the three
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Brivo OEC715/785/865 C-Arm
The Issue: GE is recalling certain lots of GE Brivo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD 200 Sterilizer (Single Door)
The Issue: Advanced Sterilization Products (ASP) is recalling the STERRAD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The
The Issue: Siemens Dimension LOCI TNI Troponin I calibrator lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquarius (TM) TEMPERATURE THERAPY
The Issue: The unit displays an error code of hose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit
The Issue: The unit displays an error code of hose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit
The Issue: The unit displays an error code of hose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit
The Issue: The unit displays an error code of hose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit
The Issue: The unit displays an error code of hose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.