Wilson-Cook Medical recalled 153 units of its Bipolar Sphincterotomes on December 18, 2025. A void in the device's material may cause an inappropriate electrical current during use. The recall affects specific models distributed in California, Colorado, Indiana, and North Carolina.
Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Wilson-Cook Medical Inc. 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 products include Teslatome Bipolar Sphincterotomes with REF numbers TESLA-B2535-260 (Model G60784) and TESLA-B2535-450 (Model G60785). Each unit has a UDI-DI code, 00827002607842 and 00827002607859 respectively. The devices were distributed in California, Colorado, Indiana, and North Carolina.
The recall addresses a potential void in the material between the wire guide and cutting wire lumens. This defect may lead to an inappropriate path of electrical current during cutting, posing a high hazard to patients.
As of the recall date, there have been no reported injuries or deaths related to this defect. However, the potential for electrical hazards necessitates immediate action.
Patients and healthcare providers should stop using the device immediately. Follow the instructions provided by Wilson-Cook Medical Inc. for returning the product.
For further details, contact Wilson-Cook Medical Inc. or your healthcare provider. Visit the official recall page at the FDA website for more instructions.
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 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.
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.