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 18801–18820 of 38,428 recalls
Recalled Item: icumedical ChemoLock Closed Vial Spike w/Skirt
The Issue: There is a potential for certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SetSource ChemoClave Vented Vial Spike
The Issue: There is a potential for certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: icumedical ChemoClave Vented Vial Spike
The Issue: There is a potential for certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: icumedical ChemoClave Vented Vial Spike
The Issue: There is a potential for certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap
The Issue: There is a potential for certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: icumedical ChemoLock
The Issue: There is a potential for certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap
The Issue: There is a potential for certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD...
The Issue: BD Synapsys version 2.1 allowed the potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FLEXIBLE NEURO-FIBERSCOPE
The Issue: The action is being initiated due to Flexible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARIES HSV 1&2 Assay
The Issue: Through internal investigation, it was discovered that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARIES C. difficile Assay
The Issue: Through internal investigation, it was discovered that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARIES Flu A/B & RSV Assay
The Issue: Through internal investigation, it was discovered that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARIES GBS Assay
The Issue: Through internal investigation, it was discovered that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARIES Group A Strep Assay
The Issue: Through internal investigation, it was discovered that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aries Bordetella Assay
The Issue: Through internal investigation, it was discovered that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARIES Extraction Kit
The Issue: Through internal investigation, it was discovered that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783
The Issue: Luminometer Malfunction May Cause Inability to Process MicroWell
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in
The Issue: Luminometer Malfunction May Cause Inability to Process MicroWell
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code:
The Issue: Luminometer Malfunction May Cause Inability to Process MicroWell
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS¿ 5600 Integrated System V3.3.2 & below Product Code:
The Issue: Luminometer Malfunction May Cause Inability to Process MicroWell
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.