FDASeptember 1, 2022device

Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the fabric does not provide the protection needed in a level 3 surgical gown, i.e., blood and other fluid may penetrate the fabric.

What to do

FDA enforcement status: Ongoing

Brands named

texas medical technologytexastexas medical

UPCs

008500229603380085002296034500850022960352

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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