FDA Device recall Z-2938-2026
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
- FDA Device
- Class II
- ongoing
- Published 2026-08-19
On 2026-08-19 the FDA classified a Class II recall of ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000 by Erbe Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2938-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-26 |
| Published | 2026-08-19 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Erbe Usa |
| Distribution | US |
Product
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Reason
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.
Identifiers
| code_info | UDI-DI 04050147013797/ Serial Numbers: All serial numbers up to 11608268 Software Version: 1.0.3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2938-2026%22
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