FDAFDA recall Z-2938-2026 · Aug 19, 2026
Erbe USA Inc: ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000 recall
Recall found
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI 04050147013797/ Serial Numbers: All serial numbers up to 11608268 Software Version: 1.0.3
- Quantity
- 1126 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 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.
- Recalling firm
- Erbe USA Inc, Marietta, GA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-26
Source: openFDA enforcement record Z-2938-2026 · search recall number Z-2938-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.