FDA · Medical devices ·
New York Embroidery Studio Trinity Non-Surgical Isolation Gown recall
New York Embroidery Studio, Inc. recalled New York Embroidery Studio Trinity Non-Surgical Isolation Gown on September 30, 2026 because of gowns do not consistently meet the minimum liquid-barrier performance required. It was sold nationwide.
Why it was recalled
Gowns do not consistently meet the minimum liquid-barrier performance required.
What's recalled
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.
Quantity: 5,400 gowns
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- New York Embroidery Studio, Inc., Brooklyn, NY
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide distribution in the state of Connecticut. - Status
- Ongoing
- Recall number
- Z-3259-2026
- Source
- U.S. Food and Drug Administration
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