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 11961–11980 of 38,428 recalls
Recalled Item: Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use
The Issue: Pressure relief valve 42 psi installed in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated...
The Issue: Pressure relief valve 42 psi installed in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HANA/PROFx CLASSIC FEMORAL HOOK RIGHT
The Issue: One batch of "regular" femoral hooks were incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref
The Issue: Calibrator vials were incorrectly labeled. Use of incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LYMOL Medical Elite X Class Rigid Bronchoscope System
The Issue: Reprocessing instructions were revised November 15, 2020, to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OASIS MRI System
The Issue: There was no label on the pad packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECHELON MRI System
The Issue: There was no label on the pad packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECHELON Oval MRI System
The Issue: There was no label on the pad packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Power Processor 3K
The Issue: Missing splash guard which may expose users to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corin Unity Knee CS Insert
The Issue: The packaging system on the devices have potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corin BIOLOX Delta Mod Head
The Issue: The packaging system on the devices have potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corin MetaFix Hip Stem
The Issue: The packaging system on the devices have potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corin TriFit TS
The Issue: The packaging system on the devices have potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corin Unity Knee Patella
The Issue: The packaging system on the devices have potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corin Unity Knee Augments
The Issue: The packaging system on the devices have potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corin Trinity-i
The Issue: The packaging system on the devices have potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corin Trinity Liner ECIMA
The Issue: The packaging system on the devices have potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corin Trinity Dual Mobility
The Issue: The packaging system on the devices have potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corin Trinity Screw
The Issue: The packaging system on the devices have potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accu-Chek Performa Test Strip
The Issue: Test strip vials may open while inside sealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.