Sobel Westex: Medical Device Recall in 2020 - (Recall #: Z-0281-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: August 13, 2020

Date Posted: October 28, 2020

Recall Number: Z-0281-2021

Event ID: 86351

Reason for Recall:

Due to non-surgical isolation gowns not meeting all performance test requirements.

Status: Terminated

Product Quantity: 3,380,850 gowns

Code Information:

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)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated