Evolve Cell Culture Bags — Class III medical device recall Z-1409-2021
Terminated recall by OriGen Biomedical, Inc., reported 2021-04-21, distributed in CA, CT, FL, IA, IL, KS, LA, MA…. It was identified that tissue culture bags were incorrectly labeled as free of phthalates.
| Recall number | Z-1409-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OriGen Biomedical, Inc., Austin, TX, United States |
| Recall initiated | 2021-01-28 |
| Classified | 2021-04-10 |
| Reported by FDA | 2021-04-21 |
| Terminated | 2023-04-19 |
| Distributed | CA, CT, FL, IA, IL, KS, LA, MA, MD, NC, NJ, NY, OH, OR, PA, PR, RI, TN, TX |
| Quantity | 1,201 units |
| Reason classes | labeling |
| Model numbers | EV1000N, EV3000N |
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
Reason for recall
It was identified that tissue culture bags were incorrectly labeled as free of phthalates.
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-1409-2021. 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.