Device recall
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
- Recall number
- Z-2938-2026
- Event id
- 99341
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Erbe USA Inc
- Report date
- Aug 19, 2026
- Initiated
- Jun 26, 2026
- Center classification date
- Aug 12, 2026
- 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.
- Quantity
- 1126 units
- Code info
- UDI-DI 04050147013797/ Serial Numbers: All serial numbers up to 11608268 Software Version: 1.0.3
- 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 Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Marietta, GA, United States