| Date Initiated by Firm | July 31, 2026 |
|---|
| Date Posted | September 23, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3259-2026 |
|---|
| Recall Event ID |
99760 |
| Product Classification |
Non-surgical gown - Product Code OEA
|
| 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. |
|---|
| Code Information |
Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.
|
| FEI Number |
3007088677
|
Recalling Firm/
Manufacturer |
New York Embroidery Studio, Inc.
140 58th St Ste A Ste 8n
Brooklyn
NY
11220-2539
|
| For Additional Information Contact |
212-971-9101 |
|---|
Manufacturer Reason
for Recall | Gowns do not consistently meet the minimum liquid-barrier performance required. |
|---|
FDA Determined
Cause 2 | 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. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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