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 35101–35120 of 38,428 recalls
Recalled Item: ADVIA Centaur Folate (100 Tests)
The Issue: Calibration failures and/or significant negative shifts in quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Visum 300 Ceiling-mounted Exam Light.
The Issue: incomplete final weld on the drop tube
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORBIT PT. The ORBIT PT works in conjunction with an
The Issue: An odor and smoke developed - The cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GYRUS ACMI
The Issue: On April 29, 2013 Olympus Surgical Technologies America
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.2mm Drill Bit. This is a component within the PediLoc
The Issue: OrthoPediatrics has initiated a voluntary recall of Part
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nestle Nutrition
The Issue: Nestle HealthCare Nutrition, Inc. is initiating a recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The
The Issue: for clinical errors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRI Cocaine Metabolite Assay
The Issue: Surveillance of reagent stability for specific lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray
The Issue: During recent revised sterilization validation testing, the included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Navigator Surgical Kit Product Usage: Molded plastic tray used in
The Issue: During recent revised sterilization validation testing, the included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used
The Issue: During recent revised sterilization validation testing, the included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage:
The Issue: During recent revised sterilization validation testing, the included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Contra-Angle Torque Driver Kit For Certain and External Connection Product
The Issue: During recent revised sterilization validation testing, the included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm
The Issue: All lots of 3.7mm and 5.0mm Dynamic Locking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MX 16-Slice CT Scanner System. Used as a whole-body computed
The Issue: A pinch point at the end of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense
The Issue: The firm issued a clinical alert after users
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL TOP (Base)
The Issue: carryover issue that can can cause shortened
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL TOP 700
The Issue: carryover issue that can can cause shortened
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL TOP CTS
The Issue: carryover issue that can can cause shortened
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL TOP 700 CTS
The Issue: carryover issue that can can cause shortened
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.