FDA-Device2026-09-30Class IIPROCESSING DEFECT
New York Embroidery Studio Trinity isolation gown recalled for inadequate liquid barrier
What this means
New York Embroidery Studio's Trinity Non-Surgical Isolation Gown (Model NYES100-2, X-Large) does not consistently provide the liquid-barrier protection it should. This means the gown may allow fluids to pass through when it should block them, potentially exposing the wearer.
- Check if you have gowns from this recall (Model NYES100-2, Lot B0676).
- Do not use affected gowns for patient care or isolation.
- Contact New York Embroidery Studio or your supplier for instructions on return or replacement.
The agency's original wording
Hazard
Gowns do not consistently meet the minimum liquid-barrier performance required.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of Connecticut.
Affected count
5,400 gowns
Manufactured in
140 58th St Ste A Ste 8n, Brooklyn, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3259-2026Want us to check the next one for you?
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