Z-Medica QuikClot Combat Gauze Recall: Sterile Barrier Risk
Z-Medica recalls QuikClot Combat Gau: Model 200 may have packaging seal breaches causing sterile barrier failure. Stop using if you own this product.
Use caution until it’s fixed
Lack of Packaging seal integrity may result in a sterile barrier breach.
Contact the company
What happened, in plain English
Z-Medica is recalling QuikClot Combat Gauze Model 200 due to potential packaging seal failures that could compromise sterility. This risk matters because it might lead to infection if the gauze is used for bleeding control. Read more at govinfonow.com/recall/61771-z-medica-quikclot-combat-gauze-recall-sterile-barrier-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/61771-z-medica-quikclot-combat-gauze-recall-sterile-barrier-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0211-2022
Cite this page
“Z-Medica QuikClot Combat Gauze Recall: Sterile Barrier Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61771-z-medica-quikclot-combat-gauze-recall-sterile-barrier-risk. Based on FDA recall #Z-0211-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0211-2022%22&limit=1).
Why it’s dangerous
The packaging seal may fail, allowing contaminants to enter the sterile gauze. This could cause infection if the gauze is used to control bleeding. The risk is specific to products without proper seal integrity.
Who’s affected
People who own or use QuikClot Combat Gauze Model 200 for temporary bleeding control are affected. Those with medical conditions requiring sterile applications may be at higher risk.
How to tell if you have this one
Check for the model number 200 on the packaging. The product was sold with lot number 12645 and UDI primary number 00841495102004.
- Brand
Z-Medica- Category
Medical device
What to do — step by step
Check Packaging Seal
Inspect the packaging for any signs of seal failure or damage.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of NC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall indicates potential packaging seal issues that could compromise sterility, so it's not recommended for use until confirmed safe.
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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-0211-2022 (September 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0211-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.