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 14861–14880 of 38,428 recalls
Recalled Item: Accurian RF Ablation
The Issue: Insertion difficulty of the probes. The probe was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accurian RF Ablation
The Issue: Insertion difficulty of the probes. The probe was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accurian RF Ablation
The Issue: Insertion difficulty of the probes. The probe was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accurian RF Ablation
The Issue: Insertion difficulty of the probes. The probe was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACTIV.A.C Therapy System
The Issue: The device may power off without notification to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips M3015A Microstream CO2 Extension Model No. 862393 -used with
The Issue: Affected M3015A extensions are incompatible with the lntelliVue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lokomat Pro
The Issue: The motor controller may fail, which can potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage:
The Issue: A missing component (hand suction pump) in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StealthStation" S7 System with Polaris Spectra Camera part number PSU
The Issue: There is a potential for specific camera units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery
The Issue: Tube material of a smaller diameter was used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component...
The Issue: ShieldLoc implant component of the ACL Reconstruction Systemlots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GlideScope Core OneTouch Smart Cable
The Issue: When video laryngoscopy system users apply, twisting motions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component...
The Issue: ShieldLoc implant component of the ACL Reconstruction Systemlots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry Calibrator
The Issue: Calibration errors have been observed with the Total
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Chemistry Calibrator
The Issue: Calibration errors have been observed with the Total
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing
The Issue: Instead of 2 doses, packaged 1 dose of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing
The Issue: Instead of 2 doses, packaged 1 dose of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAT KIT
The Issue: Instead of 2 doses, packaged 1 dose of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HealthFirst Emergency Medical Kit
The Issue: Instead of 2 doses, packaged 1 dose of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ablation Galil Technology
The Issue: The needle surface deteriorated due to unexpected electrolysis
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.