Official recall notice
FDA DeviceClass IINotable
FDA Recall: 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.
Recommended action
What to do
11226 units
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.