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Erbe USA Inc FDA Recalls
4 recalls on file across devices, 3 of them Class I and 4 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000Class IIJun 26, 2026A strong pull on the high-pressure transfer hose of cryosurg |
| Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical useClass IFeb 12, 2026Probes may rupture/burst during activation |
| Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical useClass IFeb 12, 2026Probes may rupture/burst during activation |
| Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical useClass IFeb 12, 2026Probes may rupture/burst during activation |