Recall Z-2938-2026 ยท GEH Unit, Cryosurgical, Accessories
Erbe USA Inc
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
| Date | Aug 12, 2026 (initiated Jun 26, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | On June 26, 2026, Erbe USA issued a Urgent: Medical Device Correction update notification to affected consignees via multiple methods ( Email/Website/Hand delivery). ERBE ask consignees to take the following actions: 1. We request the ERBECRYO 2 Unit be made available to the Erbe Representative to install the (V)1.0.4 Software. The Erbe Representative will perform all tasks required to update the software. 2. Confirm acknowledgement with Erbe Representative on-site. 3. Share this notice with all users within your facility. 4.While awaiting software update, there is no change of the Cryosurg |
| Quantity | 11226 units |
| Distribution | US Nationwide distribution including in the states and territories of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michig |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190651 | ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprob Erbe Elektromedizin GmbH, Jan 7, 2020 |