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 28841–28860 of 38,428 recalls
Recalled Item: Biomet Integral Centralizer Hip System
The Issue: PMMA is listed as a material on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer
The Issue: Zimmer Biomet is initiating a recall of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman...
The Issue: Stryker Sustainability Solutions is recalling the Fuhrman Pleural
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium
The Issue: AAG received a customer complaint that corrosion had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
The Issue: For the Syngo Workflow SLR System with Software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes.
The Issue: Some tubes were manufactured with the stopper not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II
The Issue: A damaged temperature sensor at the ENDOEYE tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sodium Chloride Inhalation Solution
The Issue: Lack of Assurance of Sterility: Internal dye ingress
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sodium Chloride Inhalation Solution
The Issue: Lack of Assurance of Sterility: Internal dye ingress
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NovaPACS Diagnostic Viewer versions 8.3.7
The Issue: The SUV values that are being calculated in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radiographic Transparency for Certain and External Connection Tapered...
The Issue: Images contained within radiographic transparency ART 1036 are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIRMINGHAM HIP RESURFACING MODULAR HEAD
The Issue: The 16 devices distributed in the United States
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DrugSmart Cup 10
The Issue: Ameditechs Drugs of Abuse Tests listed above have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11 Panel Card (OPI 300) w/Adult
The Issue: Ameditechs Drugs of Abuse Tests listed above have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ImmuTest Cup 7-panel w/ Adulteration
The Issue: Ameditechs Drugs of Abuse Tests listed above have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProScreen CLIA Waived Cup with 6 Drugs
The Issue: Ameditechs Drugs of Abuse Tests listed above have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Immutest 12 Panel Cup w/Adulteration
The Issue: Ameditechs Drugs of Abuse Tests listed above have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Immutest 10 Pnl Drug Screen Cup w/ Adult
The Issue: Ameditechs Drugs of Abuse Tests listed above have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProScreen Cup CLIA with 6 Panel Drug
The Issue: Ameditechs Drugs of Abuse Tests listed above have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10-Panel Pipette Drug Screen
The Issue: Ameditechs Drugs of Abuse Tests listed above have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.