TemporaryFDAOngoing
Can cause harm that is usually temporary.
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.
Check the device or its packaging for
Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.
- Why
- Gowns do not consistently meet the minimum liquid-barrier performance required.
- Distributed
- US Nationwide distribution in the state of Connecticut.
- Company
- New York Embroidery Studio, Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-3259-2026 · retrieved 23 September 2026
Read the official notice