SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP… — Class II medical device recall Z-0281-2021
Terminated recall by Sobel Westex, reported 2020-10-28, distributed nationwide. Due to non-surgical isolation gowns not meeting all performance test requirements.
| Recall number | Z-0281-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sobel Westex, Las Vegas, NV, United States |
| Recall initiated | 2020-08-13 |
| Classified | 2020-10-22 |
| Reported by FDA | 2020-10-28 |
| Terminated | 2024-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 3,380,850 gowns |
| Lot numbers | 20200405 |
| Model numbers | HGCR4958.45D-C |
Product
SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthcare personnel interactions. AAMI Level II isolation gowns are intended for relatively low risk procedures, including blood draws, lab work, or similar.
Reason for recall
Due to non-surgical isolation gowns not meeting all performance test requirements.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0281-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.