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 6281–6300 of 38,428 recalls
Recalled Item: Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V
The Issue: The incorrect device is contained in the labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Azurion Interventional Fluoroscopic X-ray Systems
The Issue: Framegrabber card may not perform as intended. Monitor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Allura Xper Interventional Fluoroscopic X-ray Systems
The Issue: Framegrabber card may not perform as intended. Monitor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Azurion Interventional Fluoroscopic X-ray Systems
The Issue: Disk Bay may not perform as intended. System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Allura Xper Interventional Fluoroscopic X-ray Systems
The Issue: Disk Bay may not perform as intended. System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Allura Xper Interventional Fluoroscopic X-ray Systems
The Issue: Dual In-Line Memory Modules (DIMMs) may not perform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3:1 Dermacarrier
The Issue: Due to manufacturing issue, the product is labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVair 03 (Jun-air) air compressor
The Issue: GE HealthCare has become aware of elevated levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MB215R - MILLS DUROGRIP TC Micro Needle Holder
The Issue: Needle Holder MB215R was inadvertently distributed as MB362R
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MB362R - JACOBSON DUROGRIP TC Micro Needle Holder
The Issue: Needle Holder MB215R was inadvertently distributed as MB362R
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ
The Issue: GE HealthCare has become aware of elevated levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVair air compressor
The Issue: GE HealthCare has become aware of elevated levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T
The Issue: An incorrect electrical shock warning label may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 3.0T
The Issue: An incorrect electrical shock warning label may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartPath to dStream for 1.5T
The Issue: An incorrect electrical shock warning label may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 1.5T
The Issue: An incorrect electrical shock warning label may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 1.5T Conversion
The Issue: An incorrect electrical shock warning label may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Ambition X
The Issue: An incorrect electrical shock warning label may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe
The Issue: The saline flush syringes may fail to meet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Samsung Digital Diagnostic Mobile X-ray System
The Issue: Mobile x-ray systems moving arm frame welding issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.