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 23741–23760 of 38,428 recalls
Recalled Item: IQon Spectral CT (Model No. 728332)
The Issue: It was reported that scanners running certain software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core (Model No. 728321)
The Issue: It was reported that scanners running certain software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance Big Bore Radiology CT (Model No. 728244) software version
The Issue: It was reported that scanners running certain software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity CT (Model No. 728326)
The Issue: It was reported that scanners running certain software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core 128 (Model No. 728323)
The Issue: It was reported that scanners running certain software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64 (Model No. 728231)
The Issue: It was reported that scanners running certain software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance iCT SP (Model No. 728311
The Issue: It was reported that scanners running certain software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance Big Bore Oncology CT (Model No. 728243) software version
The Issue: It was reported that scanners running certain software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance iCT (Model No. 728306)
The Issue: It was reported that scanners running certain software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Calibrator 30
The Issue: Siemens Healthcare Diagnostics has confirmed a negative bias
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rx series HbA1c REF/Catalog Number HA3830
The Issue: Randox confirmed low calibration absorbance with HbA1c, Catalog
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glidesheath Slender Hydrophilic Coated Introducer Sheath
The Issue: An incomplete seal at the chevron end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glidesheath Slender Hydrophilic Coated Introducer Sheath
The Issue: An incomplete seal at the chevron end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit
The Issue: An incomplete seal at the chevron end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit
The Issue: An incomplete seal at the chevron end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glidesheath Slender Hydrophilic Coated Introducer Sheath
The Issue: An incomplete seal at the chevron end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glidesheath Slender Hydrophilic Coated Introducer Sheath
The Issue: An incomplete seal at the chevron end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glidesheath Slender Hydrophilic Coated Introducer Sheath
The Issue: An incomplete seal at the chevron end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit
The Issue: An incomplete seal at the chevron end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit
The Issue: An incomplete seal at the chevron end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.