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 25521–25540 of 38,428 recalls
Recalled Item: Walgreens At-Home A1C Test Kit
The Issue: A numerical value less than 4% or greater
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K2M Special Connector Instruments (Special Connector
The Issue: Instruments were developed without adequate consideration given to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Radiology 12.2 - Picture Archive Communication System (PACS)
The Issue: Issue for customers that use an EMR login
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bariatric Bed - BARPKG-IVC 1633
The Issue: A quality issue with the junction box used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Junction Box - 1104343 and 1193560
The Issue: A quality issue with the junction box used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bariatric Bed - BAR600IVC
The Issue: The junction box used in the bariatric bed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Foot Section - BAR5490IVC
The Issue: A quality issue with the junction box used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENOVIX Guided Healing Collagen Membrane Intended for use in oral
The Issue: Lack of sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halo One 5F Introducer Sheath 90 cm Product Code: HAL590
The Issue: Complaints of sheath separation, kinking, and/or tip damage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halo One 5F Introducer Sheath 45 cm Product Code: HAL545
The Issue: Complaints of sheath separation, kinking, and/or tip damage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Pump Module
The Issue: During an infusion, a false Air-in-Line (AIL) alarm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halo One 5F Introducer Sheath 10 cm 5 pack Product
The Issue: Complaints of sheath separation, kinking, and/or tip damage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart...
The Issue: Modifications in version 13.6MR2 for Contouring, SmartAdapt, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment
The Issue: Reunion TSA Peg Alignment Sound broke during surgery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ Oncology Information System The product is used to manage
The Issue: Edits to Particle field definition parameters may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD10 722026 is intended for: Cardiovascular and vascular
The Issue: Due to a production error, screws were not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and
The Issue: Due to a production error, screws were not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and
The Issue: Due to a production error, screws were not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20 722012 is intended for: Cardiovascular and vascular
The Issue: Due to a production error, screws were not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Specimen Gate Laboratory 5002-0180
The Issue: Issue may cause eReports to consume an excessive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.