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 22421–22440 of 38,428 recalls
Recalled Item: Break-Away Femoral Nozzle
The Issue: Lack of sterility assurance as bioburden levels were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1. AutoPlex System
The Issue: Lack of sterility assurance as bioburden levels were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revolution 90 Degree Tibial Nozzle
The Issue: Lack of sterility assurance as bioburden levels were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1. InterPulse Handpiece with coaxial bone cleaning tip
The Issue: Lack of sterility assurance as bioburden levels were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 180-Gram Cement Cartridge with Breakaway Femoral Nozzle
The Issue: Lack of sterility assurance as bioburden levels were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ClariVein IC infusion catheter
The Issue: Certain catheters could have a compromised catheter shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description
The Issue: Specific lots of ArcticGel Pads have potential issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic...
The Issue: There is a potential risk of unnecessary radiation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray...
The Issue: There is a potential risk of unnecessary radiation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray...
The Issue: There is a potential risk of unnecessary radiation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system
The Issue: There is a potential risk of unnecessary radiation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0
The Issue: When an error message remains displayed and is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Brilliance iCT computed tomography x-ray system
The Issue: There is a possibility that screws holding an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Brilliance iCT SP computed tomography x-ray system
The Issue: There is a possibility that screws holding an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare IQon Spectral CT computed tomography x-ray system
The Issue: There is a possibility that screws holding an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T/Pump temperature therapy pump
The Issue: The T/Pump Operations Manual and Maintenance Manual were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Symbia Intevo 16
The Issue: The Broad Quantification option of the Symbia product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Symbia Intevo 6
The Issue: The Broad Quantification option of the Symbia product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Extension Sets with microbore tubing Model 20022 and 30914
The Issue: Reports of incorrect priming volume due to manufacturing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to
The Issue: Scalpels lot contains non-sterile products labeled as sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.