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 20581–20600 of 38,428 recalls
Recalled Item: DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084
The Issue: The hook does not securely hold the footplate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus 235
The Issue: Gantry rotation or proton irradiation can be allowed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CDI Blood parameter monitoring system 500 H/SAT
The Issue: H/Sat Hybrid Intensity Shift has been seen in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monitor with one Blood Parameter Module and one HSat Probe
The Issue: H/Sat Hybrid Intensity Shift has been seen in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instrument trays used to store AltiVate Small Shell Trials (FA
The Issue: A black, aluminum oxide coating may appear on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: This is an accessory to Intelect Advanced
The Issue: The device accessories were not labeled with appropriate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: POWERPORT CLEARVUE isp
The Issue: Certain NAUTILUS DELTA Port Kit product code /
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carl Zeiss Meditec AG
The Issue: Calibration setting was incorrectly entered during manufacturing causing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
The Issue: Recall is due to a design weakness of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product...
The Issue: hardware issue which may cause thermal effects
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial
The Issue: The povidone iodine prep pads packaged with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial
The Issue: The povidone iodine prep pads packaged with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXS PP
The Issue: After a three year term, there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUIKFLAP
The Issue: After a three year term, there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUIKFLAP
The Issue: After a three year term, there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUIKFLAP
The Issue: After a three year term, there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUIKFLAP
The Issue: After a three year term, there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXS PP
The Issue: After a three year term, there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUIKFLAP
The Issue: After a three year term, there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUIKFLAP
The Issue: After a three year term, there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.