OriGen Biomedical, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1409-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: January 28, 2021

Date Posted: April 21, 2021

Recall Number: Z-1409-2021

Event ID: 87302

Reason for Recall:

It was identified that tissue culture bags were incorrectly labeled as free of phthalates.

Status: Terminated

Product Quantity: 1201 units

Code Information:

All Lots

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated