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Open, Classified

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.

FDA Recall Z-3259-2026 · Posted 2026-09-23

Recalling FirmNew York Embroidery Studio, Inc.
Recall StatusOpen, Classified
Product CodeOEA
Date Initiated2026-07-31
Product Quantity5,400 gowns

Reason for Recall

Gowns do not consistently meet the minimum liquid-barrier performance required.

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the state of Connecticut.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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