FDAJune 1, 2017device
MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam.
What to do
FDA enforcement status: Ongoing
Brands named
master frank pinghumastermaster frank
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCOutdoor Master Children's and Youth Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory Standard for Bicycle Helmets; Sold and Imported by Outdoor Master2025-11-26
- FDACommon Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 087342022-07-15
- FDAAvant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 522532022-07-15
- FDAStage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 604402022-07-15
- FDAProtect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.2022-07-15
- FDAAvant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 622532022-07-15
- FDAProtect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 336062022-07-15
- CPSCAmerex Group Recalls Infant Fur Jackets Due to Choking Hazard2019-04-02
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