FDA recall Z-3259-2026

New York Embroidery Studio, Inc. · Class II · device

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.

Reason for recall

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

Distribution

US Nationwide distribution in the state of Connecticut.

Key facts

Status
Ongoing
Initiation date
2026-07-31
Report date
2026-09-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brooklyn, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3259-2026