CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report
Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled
New York Embroidery Studio is recalling Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large, distributed nationwide in the US. The recall was initiated on 31 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3259-2026
- FDA event ID
- 99760
- Recalling firm
- New York Embroidery Studio, Brooklyn, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Jul 2026
- FDA classified
- 23 Sep 2026
- Reported
- 30 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 31 Jul 2026 | Recall initiated by company | |
| 23 Sep 2026 | Classified by FDA | +54 days |
| 30 Sep 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Gowns do not consistently meet the minimum liquid-barrier performance required.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the state of Connecticut.
Questions about this recall
Why was it recalled?
Gowns do not consistently meet the minimum liquid-barrier performance required.
Which lots are affected?
Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.
Where was it sold?
US Nationwide distribution in the state of Connecticut.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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