New York Embroidery Studio Trinity Non-Surgical Isolation… recallZ-3259-2026 · New York Embroidery Studio, Inc. · initiated Jul 31, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from New York Embroidery Studio, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Gowns do not consistently meet the minimum liquid-barrier performance required.
FDA root cause category: Process control
What the company is doing
New York Embroidery Studio (NYES) notified the single consignee via email on 07/31/2026. The consignee was instructed to identify and remove from available inventory the three affected pallets containing Lot B0676, process the product out of inventory, segregate and ship all affected product for return to NYES.
Recall details
- Recall number
- Z-3259-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 31, 2026
- Posted by the FDA
- Sep 23, 2026
- Recalling firm
- New York Embroidery Studio, Inc.
- Quantity
- 5,400 gowns
- Product code
- OEA
- Distribution
- US Nationwide distribution in the state of Connecticut.
Product description
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.
Code information (models, lots, serial numbers)
Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NYES Trinity NYES100-2New York Embroidery Studio Inc. · Non-Surgical Gown1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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