The Recall Desk
HighFDA (Devices)·Z-1568-2026·Announced 2026-04-01

[pending] Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use

Pending LLM rewrite. Source: FDA_DEVICE Z-1568-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Probes may rupture/burst during activation

The recalled product

Product
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Manufacturer
Erbe USA Inc

Distribution

Distributed nationwide across the United States.