LotFancy recalled 91,366 urinary tract infection test strips on November 22, 2025. The strips may produce false results, risking inappropriate medical intervention. Affected products include various models sold nationwide in states like Texas, Georgia, and California.
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 recall affects 91,366 units of urinalysis test strips, including LotFancy Urinary Tract Infection Test Strips and others from brands like PALINOIA, Vaunn Medical, and JNW Direct. These products were distributed across the U.S., particularly in Texas, Georgia, and California. Models include LotFancy UTIs with expiration dates ranging from June 2026 to September 2027.
These test strips were distributed without proper FDA clearance, potentially leading to inaccurate diagnostic results. Such inaccuracies can lead to unnecessary medical treatments, posing a high risk to consumers.
There are no specific reports of injuries or deaths associated with this recall. However, the potential for misdiagnosis presents a serious health risk.
Stop using the recalled test strips immediately. Consumers should follow the recall instructions provided by the manufacturer and contact Changchun Wancheng Bio-Electron Co., Ltd. for further guidance.
For more information, contact Changchun Wancheng Bio-Electron Co., Ltd. at their official website or through the FDA recall notice.
Get instant alerts for recalls that affect you. Free forever.
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,057 bags of Acyclovir Sodium Injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers should cease use immediately and contact the manufacturer for guidance.
Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.
Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,410 bags of ketamine HCl injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers and consumers must stop using this product immediately.
Fresenius Kabi Compounding recalled 10,548 bags of thiamine HCl injection on February 5, 2026. The recall follows a lack of assurance of sterility, posing a high health risk. Affected products include several lots expiring between February and May 2026.
Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.
Pro Numb Tattoo Numbing Spray was recalled due to cGMP deviations. The recall affects products distributed nationwide in the USA. Consumers should stop using the spray immediately and contact Pro Numb Tattoo Numbing Spray LLC for guidance.