Medical Devices That Appear to Be Adulterated Because Their Quality Falls Below That Which They Purport or Are Represented to Possess

Why FDA issued it

Note: The revision of this Import Alert, dated 07/19/2017, updates the "Reason for Alert" section. Changes are bracketed by asterisks (***). Note: The revision of this Import Alert, dated 08/14/2020, updates the Guidance section, Contact Information, and adds the OASIS charge code to the charge section. Changes are bracketed by asterisks (***). Under section 501(c) of the Federal Food, Drug, and Cosmetic Act (the Act), a device is adulterated if its quality falls below that which it purports or is represented to possess. The Food and Drug Administration (FDA) has collected and analyzed samples of various medical devices which have not met the quality level that they purported or were represented to possess, in accordance with acceptance criteria in a standard or in a manufacturer's Quality System (QS) Regulation acceptance procedure.

Quoted from the “Reason for Alert” section of the FDA page for 89-17, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.