New York Embroidery Studio Trinity Non-Surgical Isolation Gown recall (New York Embroidery Studio, Inc.)
Medical deviceClass IIOngoing
Summary: New York Embroidery Studio, Inc. is recalling 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: Gowns do not consistently meet the minimum liquid-barrier performance required.
What is being recalled
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.
Why
Gowns do not consistently meet the minimum liquid-barrier performance required.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the state of Connecticut. (states named: Connecticut)
How to tell if yours is affected
Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3259-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 31, 2026 |
| Reported | September 30, 2026 |
| Company | New York Embroidery Studio, Inc. |
| Company location | Brooklyn, NY, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 5,400 gowns |
More recalls from New York Embroidery Studio, Inc. · all medical device recalls · recalls from July 2026