Z-2938-2026Class II

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

Name: Z-2938-2026 ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Creator: Erbe USA Inc
Published: 2026-06-26
License: https://open.fda.gov/license/

Erbe USA Inc / initiated 2026-06-26 / Open, Classified / root cause: design

FDA source

Erbe USA Inc began a recall of ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000 on 2026-06-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2938-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-26
Posted: 2026-08-12
Recalling firm: Erbe USA Inc
Product: ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Product code: GEH Unit, Cryosurgical, Accessories
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.
Root cause tag: design
FDA root cause: Device Design
Action: On June 26, 2026, Erbe USA issued a Urgent: Medical Device Correction update notification to affected consignees via multiple methods ( Email/Website/Hand delivery). ERBE ask consignees to take the following actions: 1. We request the ERBECRYO 2 Unit be made available to the Erbe Representative to install the (V)1.0.4 Software. The Erbe Representative will perform all tasks required to update the software. 2. Confirm acknowledgement with Erbe Representative on-site. 3. Share this notice with all users within your facility. 4.While awaiting software update, there is no change of the Cryosurgical Unit s intended use or performance. Please continue to follow all warnings, instructions, guidelines, etc. involved with the Unit and Cryoprobe.
Quantity in commerce: 11226 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.
Product codes and lots: UDI-DI 04050147013797/ Serial Numbers: All serial numbers up to 11608268 Software Version: 1.0.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2938-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2938-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-12

Product code GEH

K190651Class IIERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapterErbe Elektromedizin GmbH / cleared 2020-01-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)