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 20741–20760 of 38,428 recalls
Recalled Item: Single Chamber Temporary External Pacemaker
The Issue: A subset of Medtronic Model 53401 Single Chamber
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wingspan Stent System
The Issue: Use-related coating damage on delivery catheter shafts of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number:
The Issue: Distribution of unapproved product labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoWrist Suction Irrigator
The Issue: The firm has identified the potential for a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeoMed Enteral Feeding Tubes with Enteral Only Connectors
The Issue: for the tethered plug on the hub
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZ Single Cytofunnel Brown
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioGlue Spreader Tip
The Issue: The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica Microsystems products labeled as the following: Leica M320 Microscope
The Issue: failure of screws which hold the gas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fx SOLUTIONS CENTERED HEAD CoCr 50x19
The Issue: Breach in the external blister of certain lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fx SOLUTIONS OFFSET HEAD CoCr 50x20
The Issue: Breach in the external blister of certain lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 26-Lead Transfer Set for use with APEX¿ Compounding System
The Issue: There is a potential for valves on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical Handpiece
The Issue: Reprocessing instructions for the SGS/SGA Surgical Handpieces have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical Handpiece
The Issue: Reprocessing instructions for the SGS/SGA Surgical Handpieces have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Micro Surgery Handpiece SGS
The Issue: Reprocessing instructions for the SGS/SGA Surgical Handpieces have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Micro Surgery Handpiece SGA
The Issue: Reprocessing instructions for the SGS/SGA Surgical Handpieces have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Micro Surgery Handpiece SGS
The Issue: Reprocessing instructions for the SGS/SGA Surgical Handpieces have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical Handpiece
The Issue: Reprocessing instructions for the SGS/SGA Surgical Handpieces have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical Handpiece
The Issue: Reprocessing instructions for the SGS/SGA Surgical Handpieces have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Micro Surgery Handpiece SGA
The Issue: Reprocessing instructions for the SGS/SGA Surgical Handpieces have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Visualase Thermal Therapy System
The Issue: Inaccuracy of MR thermometry during MRI-guided laser ablation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.