Official recall notice

FDA DeviceClass IINotable

New York Embroidery Studio Trinity Non-Surgical Recall (Sep 2026)

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.

Recall date
2026-09-30
FDA class
Class II

Why it was recalled

Hazard

Gowns do not consistently meet the minimum liquid-barrier performance required.

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Product description

Gowns do not consistently meet the minimum liquid-barrier performance required.

Affected products

Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.

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