Topical/External Bandages, Dressings, Gauzes/Sponges and Cotton Pads Due to Microbiological Contamination

Why FDA issued it

NOTE: The revision to this import alert, dated 10/01/2024, updates import alert title, reason for alert section, guidance section including agency contacts, product description section, charge section and PAFs. Changes are bracketed by asterisks (***). ***Microbiological analysis conducted by FDA's Winchester Engineering and Analytical Center on topical/external bandages, dressings, gauzes/sponges, and/or cotton pads demonstrate that devices were contaminated with viable microorganisms using the U.S.P. Sterility Test Method. Compliance Policy Guide 300.400 (7124.01) addresses contamination of devices labeled and promoted as �Sterile� and are required to be marketed as �Sterile� in accordance with the applicable cleared premarket submission and/or device classification. It is limited to topical/external bandages, dressings, gauze/sponges and cotton pads intended for medical purposes to be

Quoted from the “Reason for Alert” section of the FDA page for 79-01, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.