ERBECRYO 2 Cryosurgical Unit
Erbe USA recalls ERBECRYO 2 Cryosurgical Unit (Model 10402-000) over risk of cryoprobe rupture from CO2 leak.
Stop using the ERBECRYO 2 Cryosurgical Unit immediately and contact Erbe USA for instructions on returning or servicing the affected unit.
Recall at a glance
- Quantity recalled
- 11226 units
Why it was recalled
Erbe USA is recalling the ERBECRYO 2 Cryosurgical Unit, Model/Catalog Number 10402-000, because a strong pull on the high-pressure transfer hose may cause a pneumatic short circuit between the gas inlet and the connector, allowing CO2 to leak into the return path. This can lead to excessive pressure and cause the cryoprobe to rupture.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
- Lot code
- All serial numbers up to 11608268 Software Version: 1
- UDI-DI
- 04050147013797, 11608268
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Other recent recalls from Erbe USA Inc
Editorial summary by Recall Canary · summary updated 2026-08-13 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification