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 27601–27620 of 38,428 recalls
Recalled Item: SurgiCounter scanner
The Issue: The affected scanner does not correctly interact with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded
The Issue: The device may have a defect in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver
The Issue: Multiple lots of the 26-FNLDRIVER, may have reduced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD-Retic-Count Reticulocyte Reagent System
The Issue: The carton label for one lot of BD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Navigation O-arm 02 surgical x-ray imaging system
The Issue: Review of on-system electronic product labeling and Instr
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027
The Issue: It has been discovered that replacement x-ray generator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Assays: Uric Acid (URCA)
The Issue: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advia Chemistry Assay: LDL Cholesterol
The Issue: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Assays: Triglycerides (TGL)
The Issue: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose &
The Issue: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Assays: ENZYMATIC CREATININE
The Issue: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Assays: Direct HDL Cholesterol (AHDL)
The Issue: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Assays: Triglycerides (TRIG)
The Issue: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY...
The Issue: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
The Issue: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Assays: Uric Acid (URCA)
The Issue: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
The Issue: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advia Chemistry Assay: Uric Acid and Uric Acid
The Issue: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol
The Issue: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.