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 20521–20540 of 38,428 recalls
Recalled Item: iTOVi Tracker/Scanner
The Issue: The device and its accessories may not have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Waterpik Sonic-Fusion Professional
The Issue: Charging base may overheat with localized melting and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0
The Issue: An incorrect control board and firmware installed in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is
The Issue: Atellica Solution system software (SW) version 1.13 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is
The Issue: Atellica Solution system software (SW) version 1.13 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is
The Issue: Atellica Solution system software (SW) version 1.13 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is
The Issue: Atellica Solution system software (SW) version 1.13 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is
The Issue: Atellica Solution system software (SW) version 1.13 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution
The Issue: Atellica Solution system software (SW) version 1.13 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pure Rayz
The Issue: Quasar did not receive FDA clearance for claims
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quasar MD Plus
The Issue: Quasar did not receive FDA clearance for claims
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baby Quasar Plus
The Issue: Quasar did not receive FDA clearance for claims
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow)
The Issue: Packages labeled as containing 110mm rods may contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3D V
The Issue: In rare cases of insufficient maintenance or high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hitachi Scenaria CT system Product Usage: The SCENARIA CT system
The Issue: The firm received a complaint where, during patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3D TOP Ceiling Stand
The Issue: In rare cases of insufficient maintenance or high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage:
The Issue: QFix has advised Mevion Medical Systems that they
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT
The Issue: There is a potential for the knob assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAYFIELD INFINITY XR2 BASE UNIT
The Issue: There is a potential for the knob assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT
The Issue: There is a potential for the knob assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.