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 27401–27420 of 38,428 recalls
Recalled Item: iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is...
The Issue: The study is archived but cannot be opened
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iConnect Enterprise Archive software.
The Issue: The versions allow images to be stored without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Cardio software.
The Issue: Cardio study list does not show STAT studies
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Eye Station Import Utility (ESIU). The firm name on
The Issue: System locks up which may result in potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Cardio software using EchoIMS. The firm name on the
The Issue: A situation can occur allowing two physicians to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iConnect Enterprise Archive when used with RadSuite. The firm name
The Issue: The software produced a number of "do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic
The Issue: In some instances, the system will lock tabs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge PACS software. The firm name on the label is Merge Healthcare.
The Issue: Studies that have QC, PDE, or HL7 ADT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Cardio software. The firm name on the label is Merge Healthcare
The Issue: When taking measurements from images on the Cardio
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge PACS software. The firm name on the label is Merge Healthcare
The Issue: exists for an incorrect patient image being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProSpore 4 mL Ampoule Biological indicator for steam sterilization
The Issue: Product resistance has fallen outside of label claim
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or
The Issue: Device packaging may not be sealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175
The Issue: Device packaging may not be sealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile
The Issue: This lot of the 5.0 mm Periprosthetic Locking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64
The Issue: Philips Healthcare received reports from the field that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity
The Issue: Philips Healthcare received reports from the field that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity...
The Issue: Philips Healthcare received reports from the field that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various trauma and sports medicine instruments and implants. Rod
The Issue: Insufficient seal strength on sterile barrier packaging. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various trauma and sports medicine instruments and implants. Spinal interlaminal
The Issue: Insufficient seal strength on sterile barrier packaging. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various trauma and sports medicine instruments and implants. Screw
The Issue: Insufficient seal strength on sterile barrier packaging. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.