Changchun Wancheng Bio-Electron Co. recalled 4,800 Exploro Male Fertility Tests on November 22, 2025. These devices may provide false diagnostic results, potentially leading to inappropriate medical interventions. Consumers should stop using the product immediately and follow recall instructions.
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.
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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The recalled product is the Exploro Highly Sensitive Male Fertility / Sperm Concentration Test. The affected lot numbers include 2025033101, 2025080801, and 2025090844, with expiration dates ranging from March 30, 2027, to September 7, 2027. The tests were distributed nationwide in Texas, Georgia, and California.
The fertility tests may yield false or inaccurate results when used by laypersons. This issue can lead to inappropriate medical interventions and misdiagnoses. The product was distributed without proper 510(k) clearance.
Stop using the product immediately. Follow the recall instructions provided by the manufacturer. Contact Changchun Wancheng Bio-Electron Co. or your healthcare provider for further instructions.
For more information, contact Changchun Wancheng Bio-Electron Co. at the phone number listed in the recall notification. Additional details can be found on the FDA website: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1263-2026.
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 instant alerts for recalls that affect you. Free forever.
Honda recalls 2025 CR-V Hybrid vehicles sold through Honda dealers nationwide after finding an improperly installed fuel feed hose that may leak. The recall is identified by Honda as TLS. Dealers will replace the fuel feed hose and install a new connector cover at no charge. Owners should contact Honda at 1-888-234-2138 for service.
Volkswagen Group of America recalls 2023-2025 Atlas, Atlas Cross Sport and 2023-2024 ID.4 models for loose bolts in the chassis, brake system and suspension. The potential consequence is loss of vehicle control and a crash risk. Owners should stop driving the vehicle and contact a dealer for inspection; recall letters were mailed on July 25, 2025.
Mercedes-Benz USA is recalling certain 2024 GLE 350 4MATIC, 2025 GLE 450e 4MATIC, and additional models sold through its dealer network. The issue involves a multi-purpose camera and rearview mirror that may detach from the windshield. Dealers will replace the windshield and reinstall the camera and mirror at no charge.
Mazda North American Operations recalls 2024-2025 Mazda3 and CX-30 vehicles after SAS units may deactivate airbags due to a low battery condition. Dealers will reprogram the SAS unit or replace it at no charge. Owner notification letters were mailed July 24, 2025.
Kia America, Inc. recalled certain 2023-2025 K5 vehicles on April 7, 2027. The recall involves rear window trim pieces that may loosen and detach, creating a road hazard. Owners should contact Kia for inspection and potential replacement of affected parts.
Kia America, Inc. is recalling 2023-2025 Kia Telluride SUVs sold through Kia dealers nationwide after interim notices warned that door belt molding trim can delaminate and detach. A detached trim piece can become a road hazard for other vehicles and increase the risk of a crash. Owners should contact Kia customer service at 800-333-4542 for inspection and repair.
Ford Motor Company recalled certain 2024-2025 Expedition vehicles due to a misaligned engine cup plug. This defect can lead to rapid oil leaks, increasing the risk of engine stalls and fires. The recall affects models with 3.5L GTDI engines, with notifications mailed on May 22, 2025.
Volkswagen Group of America, Inc. recalled certain 2024-2025 Audi Q4 E-Tron models on April 2, 2027. The on-board charger may fail, leading to a loss of drive power. This defect increases the risk of a crash.