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Medical device recall · FDA · Published July 31, 2026

New York Embroidery Studio, Inc. recalls New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2.

New York Embroidery Studio recalls Trinity Non-Surgical Isolation Gowns (Model NYES100-2) due to inconsistent liquid barrier performance. Affected units may not protect against liquid exposure during medical procedures.

🇺🇸 FDA recall #Z-3259-2026Medical deviceNew York Embroidery Studio ›
✎ GovInfoNow plain-language explainer

What happened, in plain English

New York Embroidery Studio is recalling their Trinity Non-Surgical Isolation Gowns (Model NYES100-2) because they don't consistently meet the required liquid barrier performance. This could mean the gowns fail to protect against liquid exposure during medical procedures. Read more at govinfonow.com/recall/1292668-new-york-embroidery-studio-trinity-non-surgical-isolation-gown-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/1292668-new-york-embroidery-studio-trinity-non-surgical-isolation-gown-recall · Published October 6, 2026 · Updated October 6, 2026 · FDA enforcement record: FDA #Z-3259-2026

Cite this page

“New York Embroidery Studio Trinity Non-Surgical Isolation Gown Recall: Liquid Barrier Failure.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/1292668-new-york-embroidery-studio-trinity-non-surgical-isolation-gown-recall. Based on FDA recall #Z-3259-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3259-2026%22&limit=1).

Why it’s dangerous

The gowns do not consistently meet the minimum liquid-barrier performance required by medical standards. This means they might not effectively prevent liquid exposure during medical procedures, potentially compromising infection control.

Who’s affected

Healthcare workers using these gowns for medical procedures are most at risk. The recall affects specific model numbers sold in the U.S. market.

How to tell if you have this one

Check for model number NYES100-2 on the gown's label. These gowns were sold in packs of 10 and 100 per shipping case with lot number B0676.

  • Brand
    New York Embroidery Studio
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for model number NYES100-2 on the gown's label.

✎ GovInfoNow

Questions people ask

Why is this gown being recalled?

The gowns do not consistently meet the minimum liquid-barrier performance required by medical standards.

How can I tell if I have the recalled gown?

Check for model number NYES100-2 on the gown's label. These gowns were sold in packs of 10 and 100 per shipping case with lot number B0676.

What should I do if I have the recalled gown?

The recall record does not specify a remedy, so no action is required beyond checking if you have the model number NYES100-2.

Take action

Contact New York Embroidery Studio

We’ve drafted a message you can send New York Embroidery Studio to request your refund or repair — edit it as you like.

Subject: Recall Z-3259-2026 — New York Embroidery Studio New York Embroidery Studio

Hello,

I own a New York Embroidery Studio that is covered by recall Z-3259-2026 from New York Embroidery Studio.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3259-2026 (July 31, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3259-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA