Use cautionMedical device recall · FDA · Published June 26, 2026
Erbe ERBECRYO 2 Cryosurgical Unit Recall: Risk of Cryoprobe Rupture
Erbe recalls ERBECRYO 2 Cryosurgical Units with serial numbers up to 11608268. A strong pull on the transfer hose may cause CO2 leakage and cryoprobe rupture.
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.
“Erbe ERBECRYO 2 Cryosurgical Unit Recall: Risk of Cryoprobe Rupture.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/459452-erbe-erbecryo-2-cryosurgical-unit-recall-risk-of-cryoprobe-rupture. Based on FDA recall #Z-2938-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2938-2026%22&limit=1).
Erbe USA Inc recalled the ERBECRYO 2 Cryosurgical Unit, model 10402-000, due to a hazard of CO2 leakage and potential probe rupture. The Food and Drug Administration announced this voluntary Class II recall on June 26, 2026.
How to tell if you have it
Brand: Erbe
Product: ERBECRYO 2 Cryosurgical Unit
Model/Catalog Number: 10402-000
UDI-DI: 04050147013797
Serial Numbers: All serial numbers up to 11608268
Software Version: 1.0.3
Units affected: 1126
The hazard
A strong pull on the high-pressure transfer hose may lead to a pneumatic short circuit between the gas inlet and the connector, resulting in CO2 leaking into the return path. This excessive pressure can cause the cryoprobe to rupture.
Context
GovInfoNow's records show Erbe USA Inc has one other recall on record since February 12, 2026: the Erbe Flexible Cryoprobe Recall from that date for probes that may rupture during activation. Other recent recalls of similar products include the Erbe Medical ERBEFLO 2 Endoscopy Pump Tubing Recall (March 31, 2026) and the Erbe Medical CleverCap CO2 Tubing/Cap Set Recall (March 31, 2026). The Draeger ErgoStar CM 40 Airway Connector Recall occurred on November 10, 2025.
How to tell if you have this one
Check the serial number on the unit, which should be up to 11608268. The product was sold with software version 1.0.3 and model number 10402-000.
Brand
Erbe
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Identify the serial number on your ERBECRYO 2 cryosurgical unit to confirm if it falls within the recall range (up to 11608268).
Contact Manufacturer
Contact Erbe USA Inc for further instructions on the recall process.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: 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.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2938-2026 (June 26, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2938-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.