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 21461–21480 of 38,428 recalls
Recalled Item: MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional...
The Issue: The fixation of the upper and lower tilt
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal...
The Issue: The fixation of the upper and lower tilt
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MultiDim Eleva 708032 As a multifunctional universal imaging application system
The Issue: The fixation of the upper and lower tilt
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter
The Issue: failure of sterile packaging seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length
The Issue: failure of sterile packaging seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter
The Issue: failure of sterile packaging seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4
The Issue: failure of sterile packaging seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter
The Issue: failure of sterile packaging seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter
The Issue: failure of sterile packaging seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smooth Guide Wire Bullet Tip 3.0 mm Diameter
The Issue: failure of sterile packaging seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter
The Issue: failure of sterile packaging seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter
The Issue: failure of sterile packaging seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm
The Issue: failure of sterile packaging seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter
The Issue: failure of sterile packaging seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter
The Issue: failure of sterile packaging seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part
The Issue: Medtronic has become aware that certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The PREVI¿ Color Gram dyes are used with the PREVI¿
The Issue: A shipment to Guadeloupe suffered a temperature excursions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The VITEK¿ 2 Gram Positive Susceptibility Card is intended for
The Issue: A shipment to Guadeloupe suffered a temperature excursions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is
The Issue: A shipment to Guadeloupe suffered a temperature excursions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS TOXO IgG Avidity is an automated qualitative test for
The Issue: A shipment to Guadeloupe suffered a temperature excursions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.