Class II — Beeken Biomedical, LLC
| Recalling firm | Beeken Biomedical, LLC |
|---|---|
| Registered facility | Beeken Biomedical LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Endotoxin levels exceeded allowable limits. |
| Product | NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5 |
| Quantity | 15 units |
| Distribution | US in the state of MO |
| Initiated | 2021-10-14 |
| Classified | 2021-11-26 |
| Recall number | Z-0309-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beeken Biomedical, LLC (Z-0309-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88941/
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