Class I

Medical Device Recall: Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use

Erbe USA Inc · February 12, 2026

Reason for Recall

Probes may rupture/burst during activation

Distribution

US Nationwide distribution, including Puerto Rico.

States Affected

NATIONWIDE

Quantity Affected

33390 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1566-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.