# FDA recall Z-1409-2021

> **OriGen Biomedical, Inc.** · Class III · device recall initiated 2021-01-28.

## 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.

## Distribution

US: TX, LA, IA, NC, OH, NY, MA, MD, IL, PA, CA, KS, TN, RI, OR, FL, NJ, CT,  Puerto Rico  OUS: None

## Key facts

- **Recall number:** Z-1409-2021
- **Recalling firm:** OriGen Biomedical, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-28
- **Report date:** 2021-04-21
- **Termination date:** 2023-04-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1409-2021

## Citation

> AI Analytics. FDA recall Z-1409-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1409-2021. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*