Recall Z-2938-2026
Erbe USA Inc · initiated June 26, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Codes / lots: UDI-DI 04050147013797/ Serial Numbers: All serial numbers up to 11608268 Software Version: 1.0.3
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.
FDA-determined cause: Device Design
Action taken
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 Cryosurgical Unit s intended use or performance. Please continue to follow all warnings, instructions, guidelines, etc. involved with the Unit and Cryoprobe.
Details
- Recall number
- Z-2938-2026
- Initiated
- June 26, 2026
- Posted by FDA
- August 12, 2026
- Product code
- GEH – Unit, Cryosurgical, Accessories
- 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, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New…
- Recalling firm
- Erbe USA Inc, Marietta, GA