ERBECRYO 2 Cryosurgical Unit recallZ-2938-2026 · Erbe USA Inc · initiated Jun 26, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Erbe USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2938-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 26, 2026
- Posted by the FDA
- Aug 12, 2026
- Recalling firm
- Erbe USA Inc
- Quantity
- 11226 units
- Product code
- GEH
- FDA submissions
- K190651
- 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 description
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Code information (models, lots, serial numbers)
UDI-DI 04050147013797/ Serial Numbers: All serial numbers up to 11608268 Software Version: 1.0.3
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ERBE 10402-000Erbe Elektromedizin GmbH · Unit, Cryosurgical, Accessories1 recall0 reports
Other devices under the same FDA submission
3 devices cleared under K190651 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ERBE 20402-401Erbe Elektromedizin GmbH · Unit, Cryosurgical, Accessories1 recall0 reports
- ERBE 20402-410Erbe Elektromedizin GmbH · Unit, Cryosurgical, Accessories1 recall0 reports
- ERBE 20402-411Erbe Elektromedizin GmbH · Unit, Cryosurgical, Accessories1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page