Class II
Medical Device Recall: 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.
New York Embroidery Studio, Inc. · July 31, 2026
Reason for Recall
Gowns do not consistently meet the minimum liquid-barrier performance required.
Distribution
US Nationwide distribution in the state of Connecticut.
States Affected
NATIONWIDE
Quantity Affected
5,400 gowns
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3259-2026
Status: ongoing
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