Press Release
URGENT: Voluntary Nationwide Recall of Urine Test Strips
February 14, 2026
Changchun Wancheng Bio-Electron Co., Ltd. Issues Voluntary Nationwide Recall of All Urine Test Strips Distributed in the United States
Changchun, China – Changchun Wancheng Bio-Electron Co., Ltd. is voluntarily recalling all lots of Urine Test Strips (including Single-Parameter and Multi-Parameter configurations) distributed to the United States market.
Reason for Recall: These products were distributed without the required FDA 510(k) premarket notification clearance. While some products may have been labeled for “educational” or “wellness” purposes, the US FDA has determined that these devices are regulated medical devices intended for near-patient testing and are not exempt from 510(k) requirements. Consequently, the safety and effectiveness of these devices for Over-The-Counter (OTC) use have not been reviewed by the FDA.
Risk Statement: For products intended for diagnostic or screening use (e.g., Sodium, UTI, Ketone, pH, etc.), there is a potential risk of false results (false positives or false negatives).
- False positives could lead to unnecessary medical procedures or anxiety.
- False negatives could lead to a delay in diagnosis or treatment of an underlying condition. To date, Changchun Wancheng has not received any reports of adverse events related to these products.
Affected Products: This recall covers ALL urine test strips manufactured by Changchun Wancheng and distributed in the US, regardless of the brand name on the box. These products may have been sold under various brand names, including but not limited to:
- Vivoo (e.g., Sodium, pH, Ketone, Protein, Vitamin C, Hydration)
- Urinify (e.g., Strength, Essential, UTI)
- HealthyWiser
- And other private labels manufactured by Changchun Wancheng.
Action Required:
- Consumers: If you have these test strips in your possession, stop using them immediately. Destroy the product or return it to the place of purchase. Do not rely on results from these devices for any medical decision-making.
- Distributors/Resellers: Stop all sales and distribution immediately. Quarantine existing inventory and contact Changchun Wancheng for disposal or return instructions.
Contact Information: Consumers or distributors with questions regarding this recall may contact Changchun Wancheng Bio-Electron Co., Ltd. at:
- Email: sales01@ccwancheng.com
- Phone: +86 431 86011111
- Hours of Operation: Monday – Friday, 9:00 AM – 5:00 PM (Local Time)
This recall is being conducted with the request of the U.S. Food and Drug Administration (FDA).