Beeken NuStat Trauma Pads: Endotoxin Risk in Bleeding Control
Beeken Biomedical recalls 5-pack NuStat 8"x12" Trauma Pads XR Hemafiber due to endotoxin levels exceeding safety limits for internal bleeding control.
Lower-risk recall
Endotoxin levels exceeded allowable limits.
Contact the company
What happened, in plain English
Beeken Biomedical is recalling 5-pack NuStat 8" x 12" Trauma Pad XR Hemafiber products because they contain endotoxin levels that exceed safe limits for temporary internal bleeding control. This could pose a health risk if used improperly. Read more at govinfonow.com/recall/61683-beeken-nustat-trauma-pads-endotoxin-risk-in-bleeding-control.
Source Summary by GovInfoNow · govinfonow.com/recall/61683-beeken-nustat-trauma-pads-endotoxin-risk-in-bleeding-control · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0309-2022
Cite this page
“Beeken NuStat Trauma Pads: Endotoxin Risk in Bleeding Control.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61683-beeken-nustat-trauma-pads-endotoxin-risk-in-bleeding-control. Based on FDA recall #Z-0309-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0309-2022%22&limit=1).
Why it’s dangerous
The trauma pads contain endotoxin levels that exceed allowable limits. Endotoxins are bacterial components that can cause health issues when introduced into the body, particularly in medical applications where internal bleeding is being controlled.
Who’s affected
Users of these trauma pads for internal bleeding control are affected. Medical professionals and emergency responders who use the product are most at risk.
How to tell if you have this one
Check for the product name 'NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack' with lot code 20C015 and UDI 00850 0392006544. These were sold with reference number XR-0812-5.
- Brand
Beeken Biomedical- Category
Medical device
What to do — step by step
Check Product Details
Verify the lot code (20C015) and UDI (00850392006544) on the product packaging.
Where it went and when
Where it was distributed
Distributed in Missouri.
FDA distribution: “US in the state of MO” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Missouri.
Recall timeline
FDA published this recall 55 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
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-0309-2022 (October 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0309-2022 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.