FDA Medical devices recall ·
New York Embroidery Studio Trinity Non-Surgical Isolation Gown… recall
- Recall number
- Z-3259-2026
- Date
- (initiated July 31, 2026)
- Company / brand
- New York Embroidery Studio, Inc.
140 58th St Ste A Ste 8n, Brooklyn, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5,400 gowns
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Gowns do not consistently meet the minimum liquid-barrier performance required.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.
Distribution
US Nationwide distribution in the state of Connecticut.
States: Connecticut
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3259-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.