Master & Frank (Pinghu) Co., Ltd. recalls MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use
MEDLINE recalls sterile surgical gowns with potential fluid leakage through sleeve seams. Learn product details and safety steps to avoid infection risks during medical procedures.
Lower-risk recall
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.
Contact the company & request your remedy
What happened, in plain English
MEDLINE is recalling surgical gowns that may allow fluid to leak through the sleeve seam, which could increase infection risk during medical procedures. This issue affects gowns sold with specific lot numbers and packaging. Read more at govinfonow.com/recall/73982-medline-sirus-surgical-gown-recall-fluid-leakage-risk-in-sleeve.
Source Summary by GovInfoNow · govinfonow.com/recall/73982-medline-sirus-surgical-gown-recall-fluid-leakage-risk-in-sleeve · Updated September 23, 2026 · FDA enforcement record: FDA #Z-3079-2017
Cite this page
“MEDLINE SIRUS Surgical Gown Recall: Fluid Leakage Risk in Sleeve Seam.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73982-medline-sirus-surgical-gown-recall-fluid-leakage-risk-in-sleeve. Based on FDA recall #Z-3079-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3079-2017%22&limit=1).
Why it’s dangerous
The breathable film sleeve seam has inconsistent sealing, which might let fluids pass through the protective layer. This could compromise the gown's ability to prevent contamination during medical procedures.
Who’s affected
Healthcare workers using these surgical gowns during procedures are most at risk. Patients undergoing surgery with these gowns could face potential infection exposure.
How to tell if you have this one
Check for the product name 'MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use'. Look for lot/serial number 45016070513PH on the packaging.
- Brand
MEDLINE- Category
Medical device
What to do — step by step
Check Product Details
Identify the product by checking the packaging for the lot/serial number 45016070513PH.
Questions people ask
Is this recall affecting my current surgical gowns?
The recall applies to specific lot numbers and packaging. Check your gown's lot/serial number to see if it's affected.
How can I tell if my gown has the leaky sleeve seam?
The recall states the sleeve seam may have inconsistent sealing, but visual inspection alone cannot confirm the issue. Only the specific lot number 45016070513PH is affected.
What should I do if I have the recalled gown?
The recall does not specify a remedy, so no action is required unless you have the specific lot number 45016070513PH.
Contact MEDLINE
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-3079-2017 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-3079-2017 from MEDLINE. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3079-2017 (June 1, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3079-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.