Notice names this product. New York Embroidery Studio’s New York Embroidery Studio Trinity Non-Surgical Isolation Gown is named in FDA Class II recall Z-3259-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Gowns do not consistently meet the minimum liquid-barrier performance required. Identifying details: Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.. Units affected: 5,400 gowns. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs of 10 and 100 gowns per shipping case.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Gowns do not consistently meet the minimum liquid-barrier performance required.
Company / brand: New York Embroidery Studio recalls
Affected product: New York Embroidery Studio Trinity Non-Surgical Isolation Gown recall status
Official ID Z-3259-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 12:00 PM UTC.