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 26541–26560 of 38,428 recalls
Recalled Item: SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.
The Issue: Tip Breakage at the glue joint between the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Certegra Workstation used in conjunction with Medrad Stellant CT Injection
The Issue: CertegraWorkstation when used in conjunction with the Medrad
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
The Issue: There is a potential for the needle to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion
The Issue: Siemens became aware of a potential issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system
The Issue: Siemens became aware of a potential issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: YSIO Max Product Usage: The Ysio Max is a radiographic
The Issue: Siemens became aware of a potential issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETHICON MERSILENE" Tape (also to as MERSILENETM Polyester Fiber
The Issue: ETHICON MERSILENE" Tape (also referred to as MERSILENETM
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics Patella Assembly Instrument
The Issue: Upon failure of the press-fit, the clamping sub
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROSA BRAIN 3.0.0
The Issue: Non-conforming product label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile IV Start Kits 50 units/trays per case Convenience kit
The Issue: Positive results from non-routine sterility testing commissioned by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zyno Medical Administration Set
The Issue: Administration Set potential filter leaking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zyno Medical Administration Set Sterile. Rx For Use with Zyno
The Issue: Administration Set potential filter leaking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zyno Medical Administration Set
The Issue: Administration Set potential filter leaking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zyno Medical Administration Set
The Issue: Administration Set potential filter leaking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carina Mobile Lifts
The Issue: A limited amount of Carina mobile lifts have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hospira MedNet Medication Management Suite software
The Issue: Hospira MedNet 6.1 software, in combination with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LAUREATE World Phaco System
The Issue: Steps 16-25 are missing from the LAUREATE Multipak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage:
The Issue: The ULTRASERT Delivery System from certain lots have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products TSH Reagent Pack
The Issue: A field correction was issued by the firm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.5mm Bowed Locking Compression Femur Plates
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.