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 25981–26000 of 38,428 recalls
Recalled Item: MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZEWAY 10F C120¿ S79CM D84CM Catalog # AB101078
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm
The Issue: The Drager Pendula spring arm device has a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arsenal Spinal Fixation System
The Issue: Alphatec Spine is recalling the Arsenal Spinal Fixation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test)
The Issue: Vitamin D Total- Change in Correlation Between Serum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guider Softip XF
The Issue: Firm became aware of potentially defective Guider Guide
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.