Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 85–96 of 125 recalls
The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Out of specification stability test result for the Caphosol B solution from process validation lots
Lack of sterility assurance.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
A software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.
A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.
Potential for breach of Tyvek seals.
Potential for breach of Tyvek seals.