Class II — OriGen Biomedical, Inc.
| Recalling firm | ORIGEN BIOMEDICAL, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The firm has become aware that they have distributed product that was expired. |
| Product | 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only |
| Quantity | 6 units |
| Distribution | US: TX |
| Initiated | 2019-06-24 |
| Classified | 2020-10-30 |
| Terminated | 2021-07-14 |
| Recall number | Z-0318-2021 |
| 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 — OriGen Biomedical, Inc. (Z-0318-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85124/
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