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 18821–18840 of 38,428 recalls
Recalled Item: VITROS ECi Immunodiagnostic System Product Code: 6801059 For use
The Issue: Luminometer Malfunction May Cause Inability to Process MicroWell
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code:
The Issue: Luminometer Malfunction May Cause Inability to Process MicroWell
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS¿ 3600 Immunoassay System V3.3.2 & below Product Code:
The Issue: Luminometer Malfunction May Cause Inability to Process MicroWell
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CELL-DYN Emerald analyzer
The Issue: There is a potential for the device to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive
The Issue: Deterioration of C-reactive protein (CRP) reagent in Optilite
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector
The Issue: Additional units have been identified for previous recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Foot Switches used with the following systems: 722001 Allura Xper
The Issue: Additional units have been identified for previous recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Micro Knife 5.0mm 30¿
The Issue: The product contains a misprinted expiration date on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1
The Issue: Complaints were received indicating that the outer label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE
The Issue: Complaints were received indicating that the outer label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: D-0012 3COR 12MM DISTRACTION SCREWS
The Issue: The items identified for recall are labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product
The Issue: The items identified for recall are labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: D-0014 3COR 14MM DISTRACTION SCREWS
The Issue: The items identified for recall are labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product
The Issue: The items identified for recall are labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR.
The Issue: Certain product code/lot number combinations may experience introducer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to
The Issue: Breach in the sterile barrier pouch may compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to
The Issue: Breach in the sterile barrier pouch may compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QuickTox 5 Panel Drug Screen DipCard
The Issue: Mixed Products containing QuickTox 5 Panel Drugs Screen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere Cholestech LDX Analyzer
The Issue: The polarity of the output of power supply
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kendall SCD Express Sterile Sleeves (Thigh Length)
The Issue: The product does not meet sterility requirements. Product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.