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 8861–8880 of 38,428 recalls
Recalled Item: NovaStar TS
The Issue: The magnets used in the swivel frame/tube set
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surepulse VS Cap Large component of VS Newborn
The Issue: Retroactively reported; Labeling contains incorrect sizing guide for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surepulse VS Cap Medium component of VS Newborn
The Issue: Retroactively reported; Labeling contains incorrect sizing guide for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surepulse VS Cap Small component of VS Newborn
The Issue: Retroactively reported; Labeling contains incorrect sizing guide for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surepulse VS Cap Extra Small component of VS
The Issue: Retroactively reported; Labeling contains incorrect sizing guide for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surepulse VS Cap Extra Large component of VS
The Issue: Retroactively reported; Labeling contains incorrect sizing guide for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SenSight Connector Plug
The Issue: Medtronic is requesting return of a small number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of
The Issue: Screw connection between the turbine head and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue G7m Anesthesia Gas Module
The Issue: The 866173 lntelliVue G7m Anesthesia Gas Modules could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sprint 200 wheeled stretcher
The Issue: Labeling being updated to assure user is securing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) # 9305
The Issue: Due to the detection of oil toxicity in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D...
The Issue: C-Arm unexpected movement may cause blunt trauma should
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS Biograph mCT: a) Flow 64-4R Seismic
The Issue: This is a potential problem with the locking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS Biograph Vision: a) 450
The Issue: This is a potential problem with the locking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS Biograph Horizon 3R Mobile
The Issue: This is a potential problem with the locking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Summit Medical Nasal Septal Button
The Issue: Sterile product pouches were not sealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Parietex Composite Mesh Polyester with Absorbable Collagen Film
The Issue: Collagen film was placed on the opposite side
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM Folate 140 test kit- For in vitro diagnostic
The Issue: Negative bias occurred when whole blood calibration (Atellica
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic
The Issue: Negative bias occurred when whole blood calibration (Atellica
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use
The Issue: Negative bias occurred when whole blood calibration (Atellica
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.