All Recalls

95,018 total recalls in our database

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

Dec 28, 2023 Other Drugs View Details β†’

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

Dec 28, 2023 Compounded Drugs View Details β†’

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

Dec 28, 2023 Other Drugs View Details β†’

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

Dec 28, 2023 Compounded Drugs View Details β†’

The sterility of microcatheter and infusion system devices cannot be guaranteed.

Nov 6, 2023 Surgical Instruments Nationwide View Details β†’

The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus.

Nov 30, 2023 Infusion Pumps Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.

Nov 30, 2023 Other Medical Devices Nationwide View Details β†’

Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU).

Nov 20, 2023 Other Medical Devices Nationwide View Details β†’