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

Official notice

30 Sept 2026

Last checked

6 Oct 2026

MediumFDA

An official FDA notice concerns New York Embroidery Studio. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2026-09-30. Lots: B0676. Recall numbers: Z-3259-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

5,400

Recall number

Z-3259-2026

Official notice

2026-09-30

The hazard

Health risk requiring medical assessment

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

B0676

Other

UDI-DI 10860008955149

Event Ids

99760

Recall Numbers

Z-3259-2026

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Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: New York Embroidery Studio. Contact: New York Embroidery Studio, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-3259-2026

Event id

99760

Units affected

5,400

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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