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 11981–12000 of 38,428 recalls
Recalled Item: Accu-Chek Aviva Plus Test Strip
The Issue: Test strip vials may open while inside sealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accu-Chek SmartView Test Strip
The Issue: Test strip vials may open while inside sealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accu-Chek Inform II Test Strip
The Issue: Test strip vials may open while inside sealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: for needle protector to become fully dislodge
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nutrifill Scleral
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and...
The Issue: Products may have been distributed to customers other
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lase DiscectomLase Discectomy Device Kit
The Issue: The sterile barrier seal may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential...
The Issue: Products may have been distributed to customers other
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)...
The Issue: Products may have been distributed to customers other
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of
The Issue: Products may have been distributed to customers other
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Scan Abutment SP
The Issue: Some devices are outside tolerances and showed a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Scan Abutment NP
The Issue: Some devices are outside tolerances and showed a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Scan Abutment WP
The Issue: Some devices are outside tolerances and showed a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Scan Abutment MU
The Issue: Some devices are outside tolerances and showed a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Scan Abutment SU
The Issue: Some devices are outside tolerances and showed a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Scan Abutment PCA
The Issue: Some devices are outside tolerances and showed a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity ci-series System Control Module clinical chemistry and immunoassay...
The Issue: Due to potential performance issues with software version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monaco RTP System
The Issue: If a couch is removed while a plan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Evo Universal
The Issue: Two software issues have been identified related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Evo O2
The Issue: Two software issues have been identified related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.