The FDA has initiated a Class II device recall (Z-1436-2026) for MRIMed Inc.'s MRI LED Mobile Exam Light Battery (REF SL-111). The recall is due to a defect where the battery component can overheat while charging, leading to melting of internal components and the generation of smoke. This poses a risk of fire or injury.

Manufacturers and distributors must manage this recall according to FDA guidelines. While the document does not specify a compliance deadline, affected parties should immediately review their distribution records and implement corrective actions to prevent further distribution and notify customers. Failure to comply with recall procedures can result in further FDA enforcement actions.