FDAFDA · Food and drugs·Recall number Z-3259-2026
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.
Published September 30, 2026 · Recall initiated: July 31, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Gowns do not consistently meet the minimum liquid-barrier performance required.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- New York Embroidery Studio, Inc.
- Distributor
- US Nationwide distribution in the state of Connecticut.
- Lot
- Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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Questions about this recall
Was 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. recalled?
Yes. FDA published recall Z-3259-2026 on September 30, 2026. Reported hazard: Gowns do not consistently meet the minimum liquid-barrier performance required.
What should I do if I have this product?
Voluntary: Firm initiated · E-Mail
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