Sobel Westex Disposable Isolation Gowns Recalled for Performance Failures
Sobel Westex is recalling 3,380,850 disposable isolation gowns because they did not meet all performance test requirements. The gowns were distributed nationwide in the U.S.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses or injuries, and the hazard is related to performance test failures rather than a specific acute threat like a high-risk pathogen or structural defect causing immediate harm.
Plain-English summary
Sobel Westex is recalling approximately 3,380,850 units of SOBEL WESTEX Disposable Isolation Gowns (Catalog: HGCR4958.45D-C). The recall is due to the gowns not meeting all performance test requirements. The affected product is a non-woven laminate with PE Film, made in China, and is intended for use in patient and healthcare personnel interactions during relatively low-risk procedures such as blood draws and lab work.
The recall covers specific batch and lot numbers: 20200405 (293,250 gowns), 20200425 (1,054,050 gowns), 20200502 (60,000 gowns), and 20200508 (2,033,550 gowns). These gowns were distributed nationwide in the United States, including in the state of Tennessee. No distribution outside the U.S. is reported.
Healthcare facilities and consumers should stop using the affected gowns and contact Sobel Westex for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- 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
- Manufacturer
- Sobel Westex
- Hazard
- Affected units
- 3,380,850
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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
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