Brooklyn, NY, United States
New York Embroidery Studio, Inc. recalls
1 recall recorded since 2018, most recently on 31 July 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 31 July 2026
- Reason
- Gowns do not consistently meet the minimum liquid-barrier performance required.
- Distribution
- US Nationwide distribution in the state of Connecticut.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3259-2026
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.