openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Code information
Item Code: 127-7573; UDI DI: D6620712775732; Lot #s: 2339, 2342;
Distribution pattern
US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
