FDA Device recall Z-0281-2021
SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthca…
- FDA Device
- Class II
- terminated
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class II recall of SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthca… by Sobel Westex, citing due to non-surgical isolation gowns not meeting all performance test requirements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0281-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-13 |
| Published | 2020-10-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Sobel Westex |
| Distribution | US |
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
Due to non-surgical isolation gowns not meeting all performance test requirements.
Identifiers
| code_info | Catalog: HGCR4958.45D-C Batch/Lot Numbers: - 20200405 (293,250 gowns manufactured) - 20200425 (1,054,050 gowns man…Catalog: HGCR4958.45D-C Batch/Lot Numbers: - 20200405 (293,250 gowns manufactured) - 20200425 (1,054,050 gowns manufactured) - 20200502 (60,000 gowns manufactured) - 20200508 (2,033,550 gowns manufactured) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0281-2021%22
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