- Recalling firm
- New York Embroidery Studio, Inc.
- Reason for recall
- Gowns do not consistently meet the minimum liquid-barrier performance required.
- Affected products (lot / model / serial)
- Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.
- Units affected
- 5,400 gowns
- Distribution pattern
- US Nationwide distribution in the state of Connecticut.
- Firm location
- Brooklyn, NY, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3259-2026
- Recall initiated
- July 31, 2026
- FDA classification date
- September 23, 2026
- FDA report date
- September 30, 2026
- FDA event ID
- 99760
- Last updated on HTM Vibe
- October 6, 2026
