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 8801–8820 of 38,428 recalls
Recalled Item: ACL ELITE PRO )-Analyzer designed specifically for clinical use in
The Issue: Removes the test definition for HemosIL Liquid Anti-Xa
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics
The Issue: for product manifold to crack during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BALLARD ACCESS Closed Suction System for Neonates/Pediatrics
The Issue: for product manifold to crack during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Med-Riser MR600 Patient Lift
The Issue: Risk of boom pivot failing due to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BEAR Implant (Bridge-Enhanced ACL Restoration)
The Issue: The field action was initiated in February of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET
The Issue: If, during the procedure, X-ray has been released
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency
The Issue: Cease use of the Habib EndoHPB Bipolar RF
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS pheno systems with a Siemens Healthineers table or a
The Issue: In the event of any unintended table movement,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LATITUDE NXT Remote Patient Management System
The Issue: Under specific circumstances, the U.S. product registration system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORTHOLOC 3DSi CLAW II 4 HOLE Plate
The Issue: Stryker has identified an issue that impacts two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORTHOLOC 3DSi CLAW II 4 HOLE Plate
The Issue: Stryker has identified an issue that impacts two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional
The Issue: Kits with affected microtiter plates have the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro...
The Issue: The Antibody (R2 reagent) is showing a positive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Ultra-Fine Insulin Syringe 0.5mL
The Issue: Nonsterile syringe potentially exposing the patient to pathogenic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml
The Issue: Nonsterile syringe potentially exposing the patient to pathogenic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Ultra-Fine Insulin Syringe 0.5mL
The Issue: Nonsterile syringe potentially exposing the patient to pathogenic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE.
The Issue: TFNA Femoral Nails labeled and etched as 200mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Power-PRO 2 . Intended as an ambulance cot to transport
The Issue: Transport Cot has insufficient volume of epoxy to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Ultra-Fine II Insulin Syringe 0.5mL
The Issue: Nonsterile syringe potentially exposing the patient to pathogenic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM -
The Issue: TFNA Femoral Nails labeled and etched as 200mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.