The US Food and Drug Administration (FDA) has issued a Class 2 device recall for Softmed Breathables Advanced Toric contact lenses from CooperVision. The recall was initiated on September 22, 2026 by CooperVision and was posted by the FDA on October 22, 2026. The recall says that the carton packaging incorrectly included the statement “Indicated for Extended Wear,” but the lenses are daily disposables. The extended use statement should not have appeared on the packaging because the lenses are not FDA approved for extended wear.

Recall letters were sent to customers on September 22, which urged them to check their products. If patients find that they received a product in the affected lot numbers with the extended wear statement on the packaging, the FDA recommends stopping wear immediately and returning the product to the distributor or eyecare professional.

See the recall for a full list of lot numbers.