FDA recall, , Moderate risk
Erbe USA ERBECRYO 2 Cryosurgical Unit
The ERBECRYO 2 Cryosurgical Unit can rupture its cryoprobe due to excessive pressure from a strong pull on the hose.
Summary by Recall Canary from the FDA notice
What happened
Erbe USA Inc, of Marietta, Georgia, recalled the ERBECRYO 2 Cryosurgical Unit. A strong pull on the high-pressure transfer hose of the cryosurgical unit may lead to a pneumatic short circuit between the gas inlet and the connector, resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture. The recall began on June 26, 2026, and was added to the FDA's Enforcement Report on August 12, 2026.
The recalled units were distributed nationwide across the United States, including its states and territories. The FDA classified the recall on August 12, 2026, and it was in the FDA's weekly enforcement report on August 19, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
ERBECRYO 2 Cryosurgical Unit
- Model number
- 10402-000
- UDI-DI
- 04050147013797
- 11608268
- Lot code
- All serial numbers up to 11608268 Software Version: 1
Recall details
- Company began the recall
- Sold in
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.
- Company
- Erbe USA IncMarietta, Georgia
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99341
- Recall number
- Z-2938-2026
- Quantity recalled
- 11226 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
