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New York Embroidery Studio, Inc.: New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner p

Medical DevicesSource: FDA (device) · Date: 2026-09-30

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
New York Embroidery Studio, Inc.
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.
Reason / hazard
Gowns do not consistently meet the minimum liquid-barrier performance required.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the state of Connecticut.
Recall initiated
2026-07-31
Code info
Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.
Product quantity
5,400 gowns
Voluntary mandated
Voluntary: Firm initiated
City
Brooklyn
State
NY
Country
United States
Event id
99760
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