Medical device recalls High risk

Erbe USA Inc recalls Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use

Recall date
February 12, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1566-2026
FDA classification
Class I
Brand / firm
Erbe USA Inc
Sold / distributed
US Nationwide distribution, including Puerto Rico.

Why it was recalled

Probes may rupture/burst during activation

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

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