FDA Device recall Z-3259-2026
New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large by New York Embroidery Studio, citing gowns do not consistently meet the minimum liquid-barrier performance required.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3259-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-31 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | New York Embroidery Studio |
| Distribution | US |
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.
Reason
Gowns do not consistently meet the minimum liquid-barrier performance required.
Identifiers
| code_info | Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3259-2026%22
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