FDAFDA recall Z-3259-2026 · Sep 30, 2026
New York Embroidery Studio, Inc.: New York Embroidery Studio Trinity Non-Surgical Isolation Gown recall
Recall found
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 for recall
Gowns do not consistently meet the minimum liquid-barrier performance required.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.
- Quantity
- 5,400 gowns
- Distribution
- US Nationwide distribution in the state of Connecticut.
- Recalling firm
- New York Embroidery Studio, Inc., Brooklyn, NY
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-31
Source: openFDA enforcement record Z-3259-2026 · search recall number Z-3259-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.