FDA classified a Class I recall for Erbe USA Inc. Flexible Cryoprobe models REF: 20402-401 (OD 1.1mm, L1.15mm with oversheath OD 2.6mm, L817mm). The devices may rupture or burst during activation, posing a serious risk of injury or death to patients during surgical procedures. Affected products were distributed nationwide including Puerto Rico.\n\nHealthcare providers must immediately stop using these cryoprobe devices and return all affected units to Erbe USA Inc. per the recall instructions. As a Class I recall, this is the highest priority enforcement action requiring urgent response. Facilities should check their inventory for model REF: 20402-401 and contact Erbe to coordinate returns.