FDAJanuary 28, 2021device
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, Yconnect...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
It was identified that tissue culture bags were incorrectly labeled as free of phthalates.
What to do
FDA enforcement status: Terminated
Brands named
origen biomedicalorigen
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDABigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the Pen Caps (Rapid-Ac...2025-05-21
- FDACenterline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter2025-04-11
- FDAStatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing2024-11-20
- FDAStatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.2024-11-20
- FDAStatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing2024-11-20
- FDATriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)2024-11-11
- FDAPower Express, REF B909182024-07-17
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