New York Embroidery Studio recall: Trinity Non-Surgical Isolation Gown
New York Embroidery Studio, Inc. is recalling New York Embroidery Studio Trinity Non-Surgical Isolation Gown – 5,400 gowns. The U.S. Food and Drug Administration published the recall on September 30, 2026; it began on July 31, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | New York Embroidery Studio Trinity Non-Surgical Isolation Gown |
| Brand | New York Embroidery Studio |
| Company | New York Embroidery Studio, Inc. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 31, 2026 |
| Published by FDA | September 30, 2026 |
| Quantity | 5,400 gowns |
| Recall ID | 99760 |
Recalled products
- 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.
- FDA recall number
- Z-3259-2026
- Codes, lots and dates
- Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.
- Quantity
- 5,400 gowns
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99760
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Brooklyn, NY, United States
Why it was recalled
The reason the FDA lists: “Gowns do not consistently meet the minimum liquid-barrier performance required.”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide distribution in the state of Connecticut.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99760, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is New York Embroidery Studio New York Embroidery Studio Trinity Non-Surgical Isolation Gown recalled?
Yes. New York Embroidery Studio, Inc. recalled it on July 31, 2026; FDA published it September 30, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Gowns do not consistently meet the minimum liquid-barrier performance required.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.