Is Erbe USA Inc recalled?

Yes — a recall has been published. 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.

TemporaryFDAOngoing

Can cause harm that is usually temporary.

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

Check the device or its packaging for

UDI-DI 04050147013797/ Serial Numbers: All serial numbers up to 11608268 Software Version: 1.0.3

Why: 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.
Distributed: 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 Inc
Announced: 19 August 2026This is the date the recall was announced. A company may have started it weeks earlier.
Recall began: 26 June 2026

Source: FDA record Z-2938-2026 · retrieved 12 August 2026

Read the official notice

Every recall is shown word for word from the FDA and USDA, with a link to the source.