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 4421–4440 of 38,428 recalls
Recalled Item: Karl Storz - Endoskope
The Issue: Various medical device product IFUs contain reprocessing modalities
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Karl Storz - Endoskope
The Issue: Various medical device product IFUs contain reprocessing modalities
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Karl Storz - Endoskope
The Issue: Various medical device product IFUs contain reprocessing modalities
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Karl Storz - Endoskope
The Issue: Various medical device product IFUs contain reprocessing modalities
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Karl Storz - Endoskope
The Issue: Various medical device product IFUs contain reprocessing modalities
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Karl Storz - Endoskope
The Issue: Various medical device product IFUs contain reprocessing modalities
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Karl Storz - Endoskope
The Issue: Various medical device product IFUs contain reprocessing modalities
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Karl Storz - Endoskope
The Issue: Various medical device product IFUs contain reprocessing modalities
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VariSoft Infusion Set
The Issue: Specific VariSoftTM Infusion Sets were packaged using incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Centricity Universal Viewer Zero Footprint Client
The Issue: Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia...
The Issue: V90 electronic vaporizer anesthetic agent output may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide
The Issue: V90 electronic vaporizer anesthetic agent output may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia...
The Issue: V90 electronic vaporizer anesthetic agent output may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to...
The Issue: V90 electronic vaporizer anesthetic agent output may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SlideView VS200 slide viewer
The Issue: A broken fuse inside the laser that was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ClotTriever XL Catheter
The Issue: Thrombectomy system catheter instructions for use updated to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioButton with Software version 3.0.20 The BioButton System
The Issue: Software anomaly causing the skin temperature measurement accuracy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexima Regular Kit Nephrostomy Catheter System Kit
The Issue: There is the potential for holes in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical portex
The Issue: Uncertainty in the seal integrity of the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical portex
The Issue: Uncertainty in the seal integrity of the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.