Lower riskMedical device recall · FDA · Published January 28, 2021
OriGen Evolve Cell Culture Bags Recalled: Incorrect Phthalate Labeling
OriGen Biomedical recalls Evolve Cell Culture Bags (EV1000N, EV3000N) due to incorrect labeling as phthalate-free. These bags are made of EVO and contain no BPA or latex.
OriGen Biomedical is recalling Evolve Cell Culture Bags with part numbers EV1000N and EV3000N because they were incorrectly labeled as phthalate-free. This means users might be exposed to phthalates, which are chemicals that can be harmful to health, especially in sensitive applications like cell culture. Read more at govinfonow.com/recall/63341-origen-evolve-cell-culture-bags-recalled-incorrect-phthalate-labeling.
“OriGen Evolve Cell Culture Bags Recalled: Incorrect Phthalate Labeling.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63341-origen-evolve-cell-culture-bags-recalled-incorrect-phthalate-labeling. Based on FDA recall #Z-1409-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1409-2021%22&limit=1).
The FDA announced on Jan. 28, 2021, that OriGen Biomedical, Inc. is recalling Evolve Cell Culture Bags because they were incorrectly labeled as free of phthalates. The agency classified the recall as Class III.
How to tell if you have it
Brand: OriGen Biomedical
Product: Evolve Cell Culture Bags
Part numbers: EV1000N and EV3000N
Lots: All Lots
The hazard
The recall was initiated because the tissue culture bags were incorrectly labeled as free of phthalates. The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex.
Context
GovInfoNow's records show OriGen Biomedical, Inc. has 5 other recalls on record since Aug. 2, 2017. Other recent recalls of similar products include Covidien Shiley Disposable Decannulation Plug Recall (April 23, 2026) and Medline IVS Blood Culture Kits Recall (June 12, 2026).
How to tell if you have this one
Check for part numbers EV1000N or EV3000N on the bags. The bags are made of Ethyl Vinyl Olefin (EVO) and contain no BPA or latex.
Brand
OriGen Biomedical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for part numbers EV1000N or EV3000N on the bag.
Where it went and when
Where it was distributed
Distributed in 18 states and Puerto Rico.
Listed by the agency
Not listed
FDA distribution: “US: TX, LA, IA, NC, OH, NY, MA, MD, IL, PA, CA, KS, TN, RI, OR, FL, NJ, CT, Puerto Rico OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Connecticut, Florida, Illinois, Iowa, Kansas, Louisiana, Maryland, Massachusetts, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The recall states the bags were incorrectly labeled as phthalate-free, but they contain no BPA or latex. Safety depends on the specific application and potential phthalate exposure.
Do these bags contain phthalates?
The recall indicates they were incorrectly labeled as phthalate-free, so they may contain phthalates. However, the exact presence is not confirmed.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1409-2021 (January 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1409-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.