New York Embroidery Studio, Inc. recalls New York Embroidery Studio Trinity Non-Surgical Isolation Gown
- Recalling company
- 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
- Gowns do not consistently meet the minimum liquid-barrier performance required.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 31, 2026
- Reported
- Sep 30, 2026
- Distribution
- US Nationwide distribution in the state of Connecticut.
- Status
- Ongoing
- Quantity
- 5,400 gowns
- Lot / codes
- Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.
- Company location
- Brooklyn, NY
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3259-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3259-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.