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 27041–27060 of 38,428 recalls
Recalled Item: LEGION(TM) HK FEMORAL ASSEMBLY
The Issue: The surface inside of the femoral component, where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEGION(TM) HK FEMORAL ASSEMBLY
The Issue: The surface inside of the femoral component, where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEGION(TM) HK FEMORAL ASSEMBLY
The Issue: The surface inside of the femoral component, where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEGION(TM) HK FEMORAL ASSEMBLY
The Issue: The surface inside of the femoral component, where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEGION(TM) HK FEMORAL ASSEMBLY
The Issue: The surface inside of the femoral component, where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iConnect Access software. The firm name on the label is Merge Healthcare
The Issue: Software displayed incorrect prior reports in the viewport
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView XCT Model 882482
The Issue: The firm became aware of an issue where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView XCT Upgrade Model 882454
The Issue: The firm became aware of an issue where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView X
The Issue: The firm became aware of an issue where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s)
The Issue: LIFEPAK CR Plus Automated External Defibrillators (AED) or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TriFoillmaging Triumph/Triumph II Research CT scanners.
The Issue: The Firm has determined that several Triumph/Triumph II
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QuickSlide MGS-80
The Issue: Discrepant culture and gram stain results, which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CENTURION Vision System
The Issue: The grounding pin within the Power Entry Switch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Calibrator Kit 29
The Issue: Ortho Clinical Diagnostics started receiving customer complaints for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Crit Line in a Clip (CLiC). CliC P/N: CL 10041001
The Issue: Use of the Blood Pressure Graph located on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OT1000 Series Orthopedic Surgical Tables
The Issue: STERIS has identified that the pivot pin assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TI Single Vector Distractor Proximal Foot/Left
The Issue: DePuy Synthes is voluntarily initiating a recall due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TI Single Vector Distractor Body with Left Foot/20mm
The Issue: DePuy Synthes is voluntarily initiating a recall due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TI Single Vector Distractor Body with Right Foot/20mm
The Issue: DePuy Synthes is voluntarily initiating a recall due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TI Single Vector Distractor Proximal Foot/Right
The Issue: DePuy Synthes is voluntarily initiating a recall due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.