FDAClass IIFebruary 11, 2026

Vivoo Sodium Test recall

Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test

Why was Vivoo Sodium Test recalled?

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Name/Lot(Expiration): Vivoo Sodium Test/2024013123(01/30/2026); Vivoo Vitamin C Test/2024013124(01/30/2026); Vivoo Hydration Test/2024013119(01/30/2026), 2025051519(05/14/2027)

Product
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
Recalling firm
Changchun Wancheng Bio-Electron Co., Ltd.
Quantity
3,300
Distribution
US Nationwide distribution in the states of TX, GA, CA.
Recall date
February 11, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls