Class IIDeviceOngoing

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 packs of 10 and 100 gowns per shipping case.

Reason for recall

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

Details

Recall number: Z-3259-2026
Event ID: 99760
Recall initiated: Jul 31, 2026
Classified: Sep 23, 2026
Reported: Sep 30, 2026
Quantity: 5,400 gowns
Distribution: US Nationwide distribution in the state of Connecticut.
Initiated by: Voluntary: Firm initiated
Firm notification: E-Mail
Firm location: Brooklyn, NY, United States
Lot / code info: Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.