Class II U.S. Food and Drug Administration

New York Embroidery Studio Trinity Non-Surgical Isolation Gown recall: Gowns do not consistently meet the minimum liquid-barrier performance required

Recall published 25 days ago

Gowns do not consistently meet the minimum liquid-barrier performance required.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Gowns do not consistently meet the minimum liquid-barrier performance required.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3259-2026
Published
September 30, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
New York Embroidery Studio, Inc.
Product type
Medical devices
Units affected
5,400 gowns
Distribution
Nationwide
Made in
United States
Lot / code info
Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.

Products covered by this recall

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.

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • B0676. — 5
  • 400 gowns

Model or item number

On the rating label, the box or the instruction sheet.

  • 100 go
  • NYES100-02. Primary DI00860008955142. UDI-DI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

New York Embroidery Studio, Inc. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: New York Embroidery Studio, Inc. — 140 58th St Ste A Ste 8n, Brooklyn, NY, 11220-2539

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was New York Embroidery Studio, Inc. medical devices recalled?

Gowns do not consistently meet the minimum liquid-barrier performance required. Gowns do not consistently meet the minimum liquid-barrier performance required.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code B0676. — 5, 400 gowns; model number 100 go, NYES100-02. Primary DI00860008955142. UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls