New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2.
Summary
The FDA issued a Class II for New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level by New York Embroidery Studio, Inc.. Reason: Gowns do not consistently meet the minimum liquid-barrier performance required..
Details
Source
Device Recall
External ID
Z-3259-2026
Action Date
2026-09-30
Status
Ongoing
Category
device
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.
Lot/Code Info: Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.
Quantity Affected: 5,400 gowns
Reason for Recall
Gowns do not consistently meet the minimum liquid-barrier performance required.
Distribution
US Nationwide distribution in the state of Connecticut.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-31
Company
Brooklyn, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 196 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (New York Embroidery Studio, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does New York Embroidery Studio, Inc. have FDA actions?
This is the only FDA action we have on record for New York Embroidery Studio, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3259-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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