Recall Z-3259-2026 ยท OEA Non-Surgical Gown
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.
| Date | Sep 23, 2026 (initiated Jul 31, 2026) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.