Z-0281-2021Class II

SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film -

Name: Z-0281-2021 SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film -
Creator: Sobel Westex
Published: 2020-08-13
License: https://open.fda.gov/license/

Sobel Westex / initiated 2020-08-13 / Terminated / root cause: manufacturing process

FDA source

Sobel Westex began a recall of SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthcare personnel... on 2020-08-13. FDA classified it as Class II and gives the reason as "Due to non-surgical isolation gowns not meeting all performance test requirements". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0281-2021
Classification: Class II
Status: Terminated
Initiated: 2020-08-13
Posted: 2020-10-22
Terminated: 2024-07-08
Recalling firm: Sobel Westex
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.
Product code: OEA Non-Surgical Gown
Reason for recall: Due to non-surgical isolation gowns not meeting all performance test requirements.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customer Notification Letters titled "Voluntary Market Withdrawal - Customer Notification - SW-CMP0001" was sent out on 08/13/2020, 08/14/2020 and 08/25/2020 via email and telephone to a customer informing them that the Recalling Firm has become aware of non-surgical gowns labeled as Level 2 gowns do not meet the Level 2 requirements in one area of the gown. The Recalling Firm is instructing customers to: 1. Return any remaining affected gowns for a refund of the original purchase price, or 2. Return any remaining affected gowns and receive replacement of certified AAMI Level 2 isolated gowns at the Recalling Firm's expense. Customer are to contact Stan Levithan at 516-792-2152 to facilitate return and/or exchange of affected gowns.
Quantity in commerce: 3,380,850 gowns
Distribution: U.S. Nationwide distribution including in the state of TN. O.U.S.: None
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0281-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0281-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-22

Product code OEA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)