New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner pack…
New York Embroidery Studio, Inc. · Gowns do not consistently meet the minimum liquid-barrier performance required.
Open FDA's page for this record- Cfres ID
- 222422
- Product res number
- Z-3259-2026
- Event date initiated
- 2026-07-31
- Event date posted
- 2026-09-23
- Recall status
- Open, Classified
- Res event number
- 99760
- Product code
- OEA
- Code info
- Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.
- Firm FEI number
- 3007088677
- Recalling firm
- New York Embroidery Studio, Inc.
- Address 1
- 140 58th St Ste A Ste 8n 140 58th St
- Address 2
- Ste A Ste 8n
- State
- NY
- Postal code
- 11220-2539
- Additional info contact
- 212-971-9101
- Reason for recall
- Gowns do not consistently meet the minimum liquid-barrier performance required.
- Root cause description
- Process control
- Product quantity
- 5,400 gowns
- Distribution pattern
- US Nationwide distribution in the state of Connecticut.
- 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.
- Action
New York Embroidery Studio (NYES) notified the single consignee via email on 07/31/2026. The consignee was instructed to identify and remove from available inventory the three affected pallets containing Lot B0676, process the product out of inventory, segregate and ship all affected product for return to NYES.
- Harmonized identifiers (openFDA)
- Device name
- Non-Surgical Gown
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4040
- Device class
- 1
- Registration number
- 3023809973, 3010353405, 3014409525, 3006157842, 3008339799, 3006400320, 3005997949, 3007615588, 3004111573, 1064619, 3032747418, 3016622475, 1055892, 3039410555, 3007539307, 3011371465, 3009308092, 3008959420, 3017461134, 3005621808, 3035252867, 1058397, 3008374630, 3003348807, 3015501220, 1836161, 3006973666, 3010865508, 3004605493, 3017911878, 3029742857, 3016615220, 3015219076, 3017059795, 2182303, 3008773774, 3016509375, 3016989300, 8030607, 3008058406 +522 more
- FEI number
- 3003255800, 3023809973, 3010353405, 3014409525, 3006157842, 3008339799, 3010862763, 3006400320, 3005997949, 3007615588, 3004111573, 3032747418, 3016622475, 3039410555, 3007539307, 3011371465, 3009308092, 3008959420, 3017461134, 3005621808, 3035252867, 1000137528, 3008374630, 3003348807, 3015501220, 3006973666, 3010865508, 3004605493, 3017911878, 3029742857, 3016615220, 3015219076, 3017059795, 3008773774, 3016509375, 3016989300, 3005846326, 3008058406, 3001650535, 2523138 +522 more