OriGen Evolve Cell Culture Bags Recalled for Incorrect Phthalate Labeling
OriGen Biomedical is recalling Evolve Cell Culture Bags because they were incorrectly labeled as free of phthalates.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a minor labeling error regarding phthalate content, fitting the criteria for a moderate severity score.
Plain-English summary
OriGen Biomedical, Inc. is recalling Evolve Cell Culture Bags, part numbers EV1000N and EV3000N. The recall involves 1,201 units of the product. The bags are made of Ethyl Vinyl Olefin (EVO) and may be supplied with tubing sets containing various components such as EVA/PVC coextruded tubing, PVC tubing, and connectors.
The recall was initiated because the tissue culture bags were incorrectly labeled as free of phthalates. This labeling error affects the accuracy of the product's safety information regarding chemical composition.
The affected units were distributed in the United States to the following states and territories: Texas, Louisiana, Iowa, North Carolina, Ohio, New York, Massachusetts, Maryland, Illinois, Pennsylvania, California, Kansas, Tennessee, Rhode Island, Oregon, Florida, New Jersey, Connecticut, and Puerto Rico. No distribution outside the United States is reported. Users should verify the labeling on their products and contact the manufacturer for further instructions.
The recalled product
- 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…
- Manufacturer
- OriGen Biomedical, Inc.
- Hazard
- Affected units
- 1,201
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
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