FDA Medical Device Recalls (openFDA)
OriGen Biomedical, Inc.: 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
- Recall number
- Z-1409-2021
- Recalling firm
- OriGen Biomedical, Inc.
- 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
- Status
- Terminated
- Initiated
- 2021-01-28
- Posted
- 2021-04-10
- Terminated
- 2023-04-19
- Reason
- It was identified that tissue culture bags were incorrectly labeled as free of phthalates.
- Root cause
- Labeling False and Misleading
- Action
- On 01/28/2021, Origen Biomedical, Inc. sent an "Technical Bulletin" via email to all affected consignees. On 4/12/21, the firm followed up a "Urgent: Medical Device Removal notification issued via E-Mail. In addition to informing consignees about the recall and technical bulletin, the The technical bulletin informed consignees about the following items: 1. Identify and quarantine any devices from the lots listed in this notice. 2. If affected product per Table 1 is identified, complete OriGens Material Return Authorization form (RD36), attached as Annex I to this notice. a. Leave the RMA # (assigned by OriGen to Customer) blank b. In Reason for Return: section, please write FA_2020_001 3. Send the RD36 form to OriGen Customer Service (info@origenbio.com). OriGen Customer Service will provide a return label, an RMA# to enter on the RD36 form, and will issue a credit for the product. 4. Appropriately package the rejected product and return to OriGen using the supplied return label. 5. Please complete the Field Action Customer Reply Form attached as Annex II to this notice, scan and send to OriGen Customer Service (info@origenbio.com). Please complete this form even if you do not have any affected product. 6. This information and instruction must be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred and remain unused. 7. If you should have any questions or concerns regarding this field notice, please contact Richard Martin, Recall Coordinator, at d.martin@origenbio.com or at 512-474-7278. 8. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Quantity
- 1201 units
- Distribution
- US: TX, LA, IA, NC, OH, NY, MA, MD, IL, PA, CA, KS, TN, RI, OR, FL, NJ, CT, Puerto Rico OUS: None
- Lot, serial or model codes
- All Lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KJA
- Firm FEI
- 1000160256
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28