NuStat 8" x12" Trauma Pad XR Hemafiber — Class II medical device recall Z-0309-2022
Ongoing recall by Beeken Biomedical, LLC, reported 2021-12-08. Endotoxin levels exceeded allowable limits.
| Recall number | Z-0309-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beeken Biomedical, LLC, Stoughton, MA, United States |
| Recall initiated | 2021-10-14 |
| Classified | 2021-11-26 |
| Reported by FDA | 2021-12-08 |
| Quantity | 15 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00850392006544 |
| Lot numbers | 20C015 |
| Model numbers | XR-0812-5 |
Product
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Reason for recall
Endotoxin levels exceeded allowable limits.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0309-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.