Z-3259-2026Class II

New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number...

Name: Z-3259-2026 New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number...
Creator: New York Embroidery Studio, Inc.
Published: 2026-07-31
License: https://open.fda.gov/license/

New York Embroidery Studio, Inc. / initiated 2026-07-31 / Open, Classified

FDA source

Recall record

Recall number: Z-3259-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-31
Posted: 2026-09-23
Recalling firm: New York Embroidery Studio, Inc.
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.
Product code: OEA Non-Surgical Gown
Reason for recall: Gowns do not consistently meet the minimum liquid-barrier performance required.
FDA root cause: Process control
Action: 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.
Quantity in commerce: 5,400 gowns
Distribution: US Nationwide distribution in the state of Connecticut.
Product codes and lots: Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3259-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3259-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-23

Product code OEA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-29. View this recall on fda.gov (opens on fda.gov)