RecallReported September 30, 2026
Class II recall by New York Embroidery Studio, Inc.
New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs…
FDA's enforcement report of September 30, 2026 lists a Class II recall by New York Embroidery Studio, Inc. of Brooklyn, NY. Product: New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs…. Status: Ongoing.
On the record
- Recalling firm
- New York Embroidery Studio, Inc.
- Location
- Brooklyn, NY
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-3259-2026
- Product type
- Devices
- Recall initiated
- 2026-07-31
- Reported by FDA
- 2026-09-30
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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