Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Evolve Cell Culture Bags Recalled by OriGen Biomedical, Inc. Due to It was identified that tissue culture bags were...

Date: January 28, 2021
Company: OriGen Biomedical, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact OriGen Biomedical, Inc. directly.

Affected Products

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

Quantity: 1201 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 18 states: CA, CT, FL, IL, IA, KS, LA, MD, MA, NJ, NY, NC, OH, OR, PA, RI, TN, TX

Affected (18 states)Not affected

About OriGen Biomedical, Inc.

OriGen Biomedical, Inc. has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report