ERBECRYO 2 Cryosurgical Unit Recall by Erbe USA Inc

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Erbe USA Inc is recalling 11,226 ERBECRYO 2 Cryosurgical Units nationwide due to risk of cryoprobe rupture from excessive pressure.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 25, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated 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.", 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.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.

What Happened

A strong pull on the high-pressure transfer hose of the cryosurgical unit may lead to a pneumatic short circuit between the gas inlet and the connector, resulting in CO2 leaking into the return path and causing excessive pressure that could rupture the cryoprobe.

Which Products Are Affected

ERBECRYO 2 Cryosurgical Unit, Model/Catalog Number: 10402-000. UDI-DI: 04050147013797. Serial numbers: all up to 11608268. Software Version: 1.0.3. 11,226 units distributed nationwide in the United States, including 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, and Wyoming. Recall number Z-2938-2026. Class II recall initiated voluntarily by Erbe USA Inc on 20260626.

What You Should Do

Consumers should follow instructions provided by the recalling firm regarding the affected devices.

Why This Matters

The defect may cause the cryoprobe to rupture during use.

Source

FDA recall Z-2938-2026

Original source: FDA Official Notice ↗

All FDA Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Erbe USA Inc is recalling 11,226 ERBECRYO 2 Cryosurgical Units nationwide due to risk of cryoprobe rupture from excessive pressure.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How is this recall classified, and why does that matter?
The FDA classifies this as a Class II recall, citing "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." as the reason. Class I is the most serious (reasonable probability of serious harm), Class II is a moderate or temporary health risk, and Class III is unlikely to cause harm.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.