Erbe USA Cryoprobe Recall - Rupture Risk

FDA classified a Class I (most serious) recall for Erbe USA Flexible Cryoprobe model REF: 20402-411, catalog number 20402-411, due to probes potentially rupturing or bursting during activation. This represents the highest risk category as the defect may cause serious injury or death during surgical procedures. The recall number is Z-1568-2026 and the action is ongoing.

Healthcare providers with these cryoprobes in inventory must immediately quarantine the devices and contact Erbe USA to arrange return. Medical device manufacturers should verify they do not hold affected inventory and notify any downstream distributors. FDA recommends healthcare facilities review their purchasing and usage records to identify potentially impacted devices. No specific return deadline is stated; however, Class I recalls require prompt action given the serious safety risk.