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 9001–9020 of 38,428 recalls
Recalled Item: SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
The Issue: A grainy image is observed when using a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc Host 2 as follows: Product SMN epoc Host 10736387
The Issue: pO2 High Recovery in Quality Control When Adjusted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc Host 2 as follows: Product SMN epoc NXS Host
The Issue: pO2 High Recovery in Quality Control When Adjusted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with
The Issue: An upward trend of complaints in which the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance...
The Issue: An upward trend of complaints in which the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance...
The Issue: An upward trend of complaints in which the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance...
The Issue: An upward trend of complaints in which the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with
The Issue: An upward trend of complaints in which the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance...
The Issue: An upward trend of complaints in which the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas infinity central lab
The Issue: A complaint investigation revealed that an incorrect behavior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal ORGAN RECOVERY PACK PGYBK
The Issue: DeRoyal is recalling certain lots of surgical procedure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedBank System - Product Label/labeling pending
The Issue: Due to customer complaints related to the MedBank
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERIFY Steam Test Pack (20 Tests and 20 controls) Item
The Issue: Biological indicator (BI) used to promote growth of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERIFY Dual Species Self-Contained Biological Indicators
The Issue: Biological indicator (BI) used to promote growth of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERIFY Steam Test Pack (20 Tests and 5 controls) Item
The Issue: Biological indicator (BI) used to promote growth of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERIFY Dual Species Self-Contained Biological Indicators
The Issue: Biological indicator (BI) used to promote growth of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD Administration Set
The Issue: There are two potential issues with CADD Infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD Administration Set
The Issue: There are two potential issues with CADD Infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD Administration Set
The Issue: There are two potential issues with CADD Infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD Administration Set
The Issue: There are two potential issues with CADD Infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.