FDAClass II · Medical device · Recall Z-3259-2026 · Recalled September 30, 2026
New York Embroidery Studio Trinity Non-Surgical Isolation Gown recall — New York Embroidery Studio, Inc.
Agency report date: September 30, 2026.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Agency product description and boundaries
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.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action
FDA reports: Gowns do not consistently meet the minimum liquid-barrier performance required.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class II: may cause temporary or medically reversible health consequences.
Affected product: New York Embroidery Studio Trinity Non-Surgical Isolation Gown recall status
3. Open the official notice or contact
View the official FDA enforcement record (openFDA) ↗
Affected products
Companies & origin
Identifying details (verbatim from the notice)
Related recalls
Other medical device recalls from around the same time
- Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED recall — Medline Industries, LPFDA · October 7, 2026
- Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories recall — Medline Industries, LPFDA · October 7, 2026
- Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5 recall — Boston Scientific CorporationFDA · September 30, 2026
- Halyard IV START KIT NON-STERILE recall — AVID Medical, Inc.FDA · September 30, 2026
- INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recall — CooperSurgical, Inc.FDA · September 30, 2026
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
Found something wrong or missing? Report a data error.
Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.