Erbe USA Inc
Device Recalls (Class I)
Class I
Z-1566-2026
·
20260401
·
Ongoing
Product
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use
Reason for Recall
Probes may rupture/burst during activation
Distribution
US Nationwide distribution, including Puerto Rico.
Source: openFDA Enforcement API