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Medical Device

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

Recall date: 2026-09-30 · Source: FDA_DEVICE
Brand / Firm
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 for recall
Gowns do not consistently meet the minimum liquid-barrier performance required.
Units affected
5,400 gowns
Description
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.
View official recall notice →