Devices Without a Unique Device Identifier and/or Matching GUDID Record

Why FDA issued it

The label and package of every medical device must bear a Unique Device Identifier (UDI) that meets the requirements of 21 CFR part 801 subpart B and part 830 when required by 21 CFR 801.20. Additionally, under 21 CFR 830.300(a) and 830.320(b), for each version or model required to bear a UDI, the labeler must submit the information required by 21 CFR part 830 subpart E to FDA's Global Unique Device Identification Database (GUDID). Devices listed on the Red List of this alert lack a required label and/or package that contains a UDI and/or lack a required GUDID record in the AccessGUDID database (https://accessgudid.nlm.nih.gov/).

Quoted from the “Reason for Alert” section of the FDA page for 99-49, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.