New York Embroidery Studio, Inc. recalls New York Embroidery Studio Trinity Non-Surgical Isolation Gown

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-3259-2026
• FDA device classification · OEAOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4040The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find New York Embroidery Studio, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.