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 6841–6860 of 38,428 recalls
Recalled Item: RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in
The Issue: RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in
The Issue: RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for
The Issue: RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INDICAID COVID-19 Rapid Antigen At-Home Test
The Issue: COVID-19 rapid antigen at home tests were released
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CD11b APC: ASR
The Issue: In vitro diagnostics product that impacts the quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black)
The Issue: Use of a 1.4 drill in hard bone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELEKTA LIMITED Elekta Infinity
The Issue: Elekta has identified that if the microswitch within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELEKTA LIMITED Elekta Synergy Platform
The Issue: Elekta has identified that if the microswitch within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELEKTA LIMITED Versa HD
The Issue: Elekta has identified that if the microswitch within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELEKTA AXESSE
The Issue: Elekta has identified that if the microswitch within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELEKTA LIMITED Elekta Synergy
The Issue: Elekta has identified that if the microswitch within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELEKTA LIMITED Precise Digital Accelerator
The Issue: Elekta has identified that if the microswitch within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only.
The Issue: Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioQuip Modular Cooler-Heater
The Issue: There is the potential that cooler-heater devices may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GRAPHENANO DENTAL G-CAM
The Issue: Machining error on cams renders the device unusable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liberty Select Cycler
The Issue: Affected Liberty Select cyclers may display an incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioQuip Modular Cooler-Heater
The Issue: There is the potential that cooler-heater devices may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Injection Needle
The Issue: The efficacy of the manual cleaning process cannot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Injection Needle
The Issue: The efficacy of the manual cleaning process cannot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Injection Needle
The Issue: The efficacy of the manual cleaning process cannot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.