FDA Medical Device Recalls (openFDA)
New York Embroidery Studio, Inc.: 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.
- Recall number
- Z-3259-2026
- 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.
- Status
- Open, Classified
- Initiated
- 2026-07-31
- Posted
- 2026-09-23
- Terminated
- not on file
- Reason
- Gowns do not consistently meet the minimum liquid-barrier performance required.
- 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
- 5,400 gowns
- Distribution
- US Nationwide distribution in the state of Connecticut.
- Lot, serial or model codes
- Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OEA
- Firm FEI
- 3007088677
- Firm city
- not on file
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28