Quick Facts at a Glance
- Recall Date
- November 22, 2025
- Hazard Level
- HIGH
- Brand
- Changchun Wancheng Bio-Electron Co.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Changchun Wancheng Bio-Electron Co.
- Product type
- Test Strips
- Model numbers
- 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)
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 22, 2025
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Changchun Wancheng Bio-Electron Co., Ltd. or your healthcare provider for instructions. Notification method: Letter
About This Product
Vivoo test strips are used for at-home health monitoring, allowing consumers to test sodium, Vitamin C, and hydration levels. They appeal to health-conscious individuals looking for convenient health management solutions.
Why This Is Dangerous
The recall stems from the distribution of test strips that lacked proper FDA approval, which can result in misleading health information for users. This may lead to unnecessary medical actions or treatments based on incorrect results.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face health risks by relying on these inaccurate test results, potentially leading to misdiagnosis or inappropriate treatment.
Practical Guidance
How to identify if yours is affected
- Check the model numbers on your test strips against those in the recall announcement.
- Verify the expiration dates to ensure they match the recalled lot numbers.
- If you have the affected products, stop use immediately.
Where to find product info
The model numbers and expiration dates can typically be found on the packaging or the test strip container itself.
What timeline to expect
Expect processing for refunds or replacements to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Reach out to the manufacturer again using different contact methods.
- Document your attempts to contact them and keep records of all correspondence.
How to prevent similar issues
- Look for FDA-approved products when purchasing health monitoring devices.
- Check for certification labels and reviews before buying similar products.
- Stay informed on current recalls in the medical device category.
Documentation advice
Keep all receipts, correspondence with the manufacturer, and any documentation related to the recall for your records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recall involves the Vivoo Sodium Test, Vivoo Vitamin C Test, and Vivoo Hydration Test. These products were distributed nationwide in Texas, Georgia, and California. They were not legally marketed in the U.S. before distribution.
Key Facts
- Recalled products: Vivoo Sodium Test, Vitamin C Test, Hydration Test
- Risk of false diagnostic results
- No reported injuries or deaths
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.