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 12001–12020 of 38,428 recalls
Recalled Item: Trilogy EV300
The Issue: Two software issues have been identified related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Evo
The Issue: Two software issues have been identified related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MIVI Super 90 8F Guide Catheter
The Issue: There is potential for nonsterility of product due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MIVI Super 90 Guide Catheters
The Issue: There is potential for nonsterility of product due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Norton Arm Kit
The Issue: Affected products were manufactured with materials found to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Hemo
The Issue: The firm identified a safety issue affecting the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jessie Sterile Arm Suspension Kit
The Issue: Affected products were manufactured with materials found to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Marco Shoulder Stabilization Kit
The Issue: Affected products were manufactured with materials found to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AUGMENT Injectable Kit
The Issue: The kit contains the wrong vial tray in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TheraSphere Administration Set
The Issue: for leaks and loosening at the patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TheraSphere Administration Set
The Issue: for leaks and loosening at the patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter prismaflex
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter PrismaFlex
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD" Mouse IgG2a Isotype Control APC X39 ASR
The Issue: Complaints have been received for performance issues related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPIQ Ultrasound Systems
The Issue: Ultrasound system control panel arm swivel lock could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-...
The Issue: Device failed to function as intended and/or failed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MPR Slotted Mallet
The Issue: for mallet head to become separated from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxA 5000 (DxA Automation System
The Issue: There is a potential that sample carriers (w
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB
The Issue: Cordis has identified that the SUPER TORQUE MB
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis SUPER TORQUE MB 5F PIG
The Issue: Cordis has identified that the SUPER TORQUE MB
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.