ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000 — Class II medical device recall Z-2938-2026
Ongoing recall by Erbe USA Inc, reported 2026-08-19, distributed nationwide. A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit betw
| Recall number | Z-2938-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Erbe USA Inc, Marietta, GA, United States |
| Recall initiated | 2026-06-26 |
| Classified | 2026-08-12 |
| Reported by FDA | 2026-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 1,126 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 04050147013797 |
| Serial numbers | 11608268 |
| Model numbers | 10402-000 |
Product
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2938-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.