Recall Z-3259-2026— New York Embroidery Studio, Inc.
Class II · Ongoing
Class II FDA medical device recall by New York Embroidery Studio, Inc., initiated 2026-07-31. FDA's recall record names no specific 510(k) clearance for this event. 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: Gowns do not consistently meet the minimum liquid-barrier performance required..
- Recalling firm
- New York Embroidery Studio, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-31
- Firm location
- Brooklyn, NY, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.