Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MEDLINE SIRUS Surgical Gown Recalled by Master & Frank (Pinghu) Co., Ltd. Due to The sleeve seam of the breathable material was...

Date: June 1, 2017
Company: Master & Frank (Pinghu) Co., Ltd.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Master & Frank (Pinghu) Co., Ltd. directly.

Affected Products

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.

Quantity: 2,160 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 1 state: IL

Affected (1 state)Not affected

About Master & Frank (Pinghu) Co., Ltd.

Master & Frank (Pinghu) Co., Ltd. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report