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.
- Recall number
- Z-3259-2026
- Event id
- 99760
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- New York Embroidery Studio, Inc.
- Report date
- Sep 30, 2026
- Posted
- Sep 23, 2026
- Initiated
- Jul 31, 2026
- Center classification date
- Sep 23, 2026
- Product code
- OEA
- Device type
- Non-Surgical Gown
- Reason
- Gowns do not consistently meet the minimum liquid-barrier performance required.
- Root cause
- Process control
- Quantity
- 5,400 gowns
- Code info
- Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.
- Distribution
- US Nationwide distribution in the state of Connecticut.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Brooklyn, NY, United States