Class III — 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 III |
| Status | Terminated |
| Reason | It was identified that tissue culture bags were incorrectly labeled as free of phthalates. |
| Product | Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing, PVC tubing, Yconnectors, needle-free valves, female luers, male luers and/or caps |
| Quantity | 1201 units |
| Distribution | US: TX, LA, IA, NC, OH, NY, MA, MD, IL, PA, CA, KS, TN, RI, OR, FL, NJ, CT, Puerto Rico OUS: None |
| Initiated | 2021-01-28 |
| Classified | 2021-04-10 |
| Terminated | 2023-04-19 |
| Recall number | Z-1409-2021 |
| 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 III recall — OriGen Biomedical, Inc. (Z-1409-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87302/
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