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 13201–13220 of 38,428 recalls
Recalled Item: Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible
The Issue: The affected Milex Gellhorn pessaries were incorrectly manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OT1000 Series Orthopedic Surgical Tables
The Issue: On January 7, 2021, STERIS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR
The Issue: R&D Systems, Inc. received two complaints that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Enteral Infusion Pump
The Issue: The potential for air appearing in the enteral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Sustainability Solutions Ethicon Endo-Surgery
The Issue: Product was distributed without receiving regulatory clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heartspan Transseptal Needles
The Issue: The labeled needle tip curvature of specific lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartSpan Transseptal Needles Catalog No. FND-019-01
The Issue: The labeled needle tip curvature of specific lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various reprocessed products: PROVISION
The Issue: Non-sterile product was shipped to customers labelled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Captivator Single-Use Polypectomy Snares
The Issue: Packaging Incomplete Seal. Users noted an incomplete pouch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares...
The Issue: Packaging Incomplete Seal. Users noted an incomplete pouch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Captivator II Single-Use Polypectomy Snares Outer box UPN
The Issue: Packaging Incomplete Seal. Users noted an incomplete pouch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM
The Issue: Distributed COVID test kits without emergency use authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tube Tracheostomy and Tube Cuff
The Issue: Smiths Medical became aware that three lot numbers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
The Issue: Sterility may be compromised due to an unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign
The Issue: Locking mechanism has been observed to disassociate either
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign
The Issue: Locking mechanism has been observed to disassociate either
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign
The Issue: Locking mechanism has been observed to disassociate either
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign
The Issue: Locking mechanism has been observed to disassociate either
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign
The Issue: Locking mechanism has been observed to disassociate either
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
The Issue: Sterility may be compromised due to an unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.