The Recall Desk
SevereFDA (Devices)·Z-2938-2026·Announced 2026-08-19

Erbe ERBECRYO 2 Cryosurgical Unit Recalled Due to Rupture Risk

Erbe USA Inc is recalling ERBECRYO 2 Cryosurgical Units because a strong pull on the high-pressure transfer hose may cause the cryoprobe to rupture.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (cryoprobe rupture) that poses a significant risk of injury to patients or providers.

Plain-English summary

Erbe USA Inc is recalling 11,226 units of the ERBECRYO 2 Cryosurgical Unit, Model/Catalog Number 10402-000. The recall covers units with UDI-DI 04050147013797 and serial numbers up to 11608268, running software version 1.0.3. These devices were distributed nationwide across all 50 states, the District of Columbia, and Puerto Rico.

The recall is due to a safety hazard where a strong pull on the high-pressure transfer hose may lead to a pneumatic short circuit between the gas inlet and the connector. This can result in CO2 leaking into the return path, causing excessive pressure that leads to the cryoprobe rupturing.

Healthcare facilities and users of these devices should stop using the affected units immediately. Users should contact Erbe USA Inc for further instructions on how to proceed with the recall.

The recalled product

Product
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Manufacturer
Erbe USA Inc
Category
Medical Device — Cryosurgical Equipment
Hazard
Affected units
1,126

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

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