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 13421–13440 of 38,428 recalls
Recalled Item: INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INJECTOR FORCEMAX LOWER 23G 5MM
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold
The Issue: Product distributed with a red tape as part
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gambro Cartridge Blood Set Prime Line
The Issue: complaints of kinked access lines observed during treatment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set
The Issue: complaints of kinked access lines observed during treatment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis
The Issue: complaints of kinked access lines observed during treatment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gambro Cartridge Blood Transport System for Hemodialysis Blood Set
The Issue: complaints of kinked access lines observed during treatment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gambro Cartridge Blood Transport System for Hemodialysis Blood Set
The Issue: complaints of kinked access lines observed during treatment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gambro Cartridge Single Needle Conversion Kit
The Issue: complaints of kinked access lines observed during treatment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG - Product
The Issue: The Quality Control (QC) card has a label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
The Issue: Missing Instruction For Use insert
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Metalogix Self-Drill Half-Pin
The Issue: Complaints were received for Self-drill Half-Pin tip breakages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tourni-Cot - Universal
The Issue: A failure can occur if the user attempts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm
The Issue: for the battery to lose its ability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade
The Issue: Patient tabletop moved out to the home position
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips EPIQ Diagnostic Ultrasound System
The Issue: Control panel arm assembly could have missing or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Deluxe IntraCervical Insemination (ICI) Kit (3)
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.