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 18881–18900 of 38,428 recalls
Recalled Item: Liquid Immunoassay Premium Controls
The Issue: The target value for uptake is incorrect on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Immunoassay Premium Controls
The Issue: The target value for uptake is incorrect on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Immunoassay Premium Plus Controls
The Issue: The target value for uptake is incorrect on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medica Wash1-Wash solution used prior to Lipase assay on the
The Issue: Wash1 solution is ineffective in cleaning dispensing probe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Na¿da CI Q70 Sound Processor
The Issue: The sound processors were loaded with the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Na¿da CI Q90 Sound Processor
The Issue: The sound processors were loaded with the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Na¿da CL Q30 Sound Processor
The Issue: The sound processors were loaded with the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LW Scientific ZIP IQ PCV Centrifuge
The Issue: The clear, plastic, polycarbonate hematocrit rotor may break
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LW Scientific ZIP IQ Combo Centrifuge
The Issue: The clear, plastic, polycarbonate hematocrit rotor may break
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LW Scientific ZIP IQ Combo Centrifuge
The Issue: The clear, plastic, polycarbonate hematocrit rotor may break
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
The Issue: Inner blister pack label is incorrect and does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT
The Issue: Patient results may be falsely elevated. This patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity
The Issue: Patient results may be falsely elevated. This patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMPOWR Locking Femoral Impactor
The Issue: The firm has received reports/complaints concerning the breakage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobas¿ infinity central lab IT solution Material Number: 07154003001...
The Issue: Using the following versions of cobas infinity software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Molift 2-Point sling bar
The Issue: The firm has received 7 reports of malfunction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Molift 2-Point sling bar
The Issue: The firm has received 7 reports of malfunction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plain and Chromic Gut Absorbable Surgical Sutures
The Issue: compromise of product sterility after routine monitoring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: US Endoscopy Padlock Clip defect closure system The
The Issue: esophageal laceration during a patient procedure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3mL Safety-Lok Syringe
The Issue: The syringes have scale markings that were printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.