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 34401–34420 of 38,428 recalls
Recalled Item: Coulter LH 780 Hematology Analyzer
The Issue: Beckman Coulter is recalling the LH 750 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VersaSafe Extension Set
The Issue: CareFusion is recalling the VersaSafe Extension Intravascular Administration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartSite Low Sorbing Infusion Set with Texium Close Male Luer
The Issue: CareFusion is recalling the SmartSite Low Sorbing Infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Teflon Tube
The Issue: Stryker became aware during laboratory testing that there
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile
The Issue: There exists a software issue associated with patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EOS System X- ray beam Digital radiography system used in
The Issue: EOS imaging discovered during production internal testing that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OrthoPediatrics ACL Reconstruction System is a pediatric and small stature
The Issue: Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens ADVIA Chemistry Systems models 1200
The Issue: The ADVIA Chemistry software systems using certain software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE/IMMULITE 1000 Systems FOL Folic Acid
The Issue: for an accelerated decline in counts per
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instrument Manager driver : Driver sysu100i that connects to the
The Issue: When connected to the Sysmex UF-100, the Instrument
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Axillent Debakey Grasping Forceps
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Candela Laser GentleLase Pro
The Issue: Unintended single pulse maybe emitted to handpiece prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NGK Stem Ext 24 x 245mm
The Issue: Based on a review of historic packaging validations,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DIST LAT FEM LOCK PLT
The Issue: Based on a review of historic packaging validations,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TIBIO FEM/FEM NAIL.
The Issue: Based on a review of historic packaging validations,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FEM COND BUTTRESS PLT
The Issue: Based on a review of historic packaging validations,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TIB NAIL
The Issue: Based on a review of historic packaging validations,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FEM COND BUTTRESS PLT
The Issue: Based on a review of historic packaging validations,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ITST THREADED GUIDE PIN
The Issue: Based on a review of historic packaging validations,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DIST LAT FEM LOCK PLT
The Issue: Based on a review of historic packaging validations,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.