Drug recall
New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number…
FDA recall event 99760 · Class II · New York Embroidery Studio, Inc.
Key facts
| Event ID | 99760 |
|---|---|
| Recall numbers | Z-3259-2026 |
| Recalling firm | New York Embroidery Studio, Inc. |
| Product type | Devices |
| 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. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Gowns do not consistently meet the minimum liquid-barrier performance required. |
| Initiation date | Jul 31, 2026 |
| Report date | Sep 30, 2026 |
| City | Brooklyn |
| State | NY |
| Country | United States |
| FEI number | 3007088677 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: