Class II — New York Embroidery Studio, Inc.
| Recalling firm | NEW YORK EMBROIDERY STUDIO |
|---|---|
| Registered facility | New York Embroidery Studio (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Gowns do not consistently meet the minimum liquid-barrier performance required. |
| Product | 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. |
| Quantity | 5,400 gowns |
| Distribution | US Nationwide distribution in the state of Connecticut. |
| Initiated | 2026-07-31 |
| Classified | 2026-09-23 |
| Recall number | Z-3259-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — New York Embroidery Studio, Inc. (Z-3259-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99760/
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