Official recall notice
FDA DeviceClass IINotable
ERBECRYO 2 Cryosurgical Unit Recall (Aug 2026) – Erbe USA
Product: ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
- Recall date
- 2026-08-19
- Brand
- Erbe USA Inc
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture.
Product description
A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture.
Affected products
UDI-DI 04050147013797/ Serial Numbers: All serial numbers up to 11608268 Software Version: 1.0.3