ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000

What happened?

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 should I do now?

1Check the lot number on your product packaging.
2If you have it, stop using it.
3Return it to your pharmacy or store for a refund.
4If you already used it and feel unwell, see your doctor immediately.
5Report adverse effects to the FDA: 1-800-FDA-1088.

Company: Erbe USA Inc
Status: Ongoing
Report date: 2026-08-19
Initiated: 2026-06-26
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.
Quantity: 11226 units

This is NOT medical advice. Consult with your pharmacist or doctor before making decisions.