Food, drugs, devices › OriGen Biomedical, Inc.
Device recall: Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and conta
FDA enforcement event 87302 is a device recall by OriGen Biomedical, Inc. of Austin, TX, initiated 28 Jan 2021 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 3% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 19 Apr 2023. Initiation: voluntary: firm initiated. OriGen Biomedical, Inc. has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
OriGen Biomedical, Inc., Austin, TX.
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"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1409-2021 | 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… | 1201 units | Class III | Terminated | 21 Apr 2021 |
Context
Other enforcement events for OriGen Biomedical, Inc.
All 9 events for OriGen Biomedical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "It was identified that tissue culture bags were incorrectly labeled as free of phthalates."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "US: TX, LA, IA, NC, OH, NY, MA, MD, IL, PA, CA, KS, TN, RI, OR, FL, NJ, CT, Puerto Rico OUS: None"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Apr 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.