[pending] Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. F
Pending LLM rewrite. Source: FDA_DEVICE Z-1566-2026.
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 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
- Manufacturer
- Erbe USA Inc
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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