# FDA recall Z-0281-2021

> **Sobel Westex** · Class II · device recall initiated 2020-08-13.

## 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.

## Distribution

U.S. Nationwide distribution including in the state of TN. O.U.S.: None

## Key facts

- **Recall number:** Z-0281-2021
- **Recalling firm:** Sobel Westex
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-13
- **Report date:** 2020-10-28
- **Termination date:** 2024-07-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Las Vegas, NV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0281-2021

## Citation

> AI Analytics. FDA recall Z-0281-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0281-2021. Source: US FDA. Licensed CC0.

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