FDA classified a Class I medical device recall for Erbe USA Inc's Flexible Cryoprobe (REF: 20402-410, OD 1.7mm, L1.15mm) after identifying that probes may rupture or burst during activation. Class I is the most serious recall classification, indicating reasonable probability of serious adverse health consequences or death. The affected product was distributed nationwide including Puerto Rico, and the recall is currently ongoing.

Healthcare providers and surgical facilities must immediately identify any Flexible Cryoprobe units matching REF: 20402-410 in their inventory, cease use of these devices, and contact Erbe USA Inc for return/replacement procedures. Medical device distributors should notify all affected customers. Failure to remove defective probes from surgical use could result in patient injury during procedures, exposing providers to significant liability and regulatory scrutiny.