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 2101–2120 of 38,428 recalls
Recalled Item: Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen
The Issue: Due to a software/firmware issue diabetes management system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LUCAS 2
The Issue: Due to demonstration units of chest compression system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Due to customer complaints, there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller
The Issue: for shorter clotting times in clotting tests
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Newport HT70 Ventilator
The Issue: Ventilator Printed Circuit Board Assembly may have two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: My3D Personalized Solutions Humeral Cup
The Issue: Required inspections were not performed on finished product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BACTEC" MGIT" 960 PZA Kit. IVD qualitative procedure for
The Issue: BD has received additional complaints of intermittent false
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ColoSense Test Kit
The Issue: Multiple plate failures documented as a result of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird
The Issue: Product packaging contains the wrong part number and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW
The Issue: There is the potential that the eccentrical adaptor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW .15.702
The Issue: There is the potential that the eccentrical adaptor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Q-Stop Product Name: Suture Retention Device Model/Catalog Number:
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare LOGIQ F R3 Ultrasound System
The Issue: GE HealthCare has become aware that the Estimated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Versana Ultrasound Systems
The Issue: GE HealthCare has become aware that the Estimated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: interventional fluoroscopic x-ray system
The Issue: In very rare situations, communication between the sensor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline UMBILICAL TRAY W/3.5&5FR CATH
The Issue: There is a possible packaging defect impacting the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: interventional fluoroscopic x-ray system
The Issue: In very rare situations, communication between the sensor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: interventional fluoroscopic x-ray system
The Issue: In very rare situations, communication between the sensor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS is a family of dedicated angiography systems developed for
The Issue: In very rare situations, communication between the sensor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife)
The Issue: The impacted tape was manufactured with incorrect information
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.