ERBECRYO 2 Cryosurgical Unit Recall by Erbe USA Inc
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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.
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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 ↗
Related FDA Recalls
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.
Similar body length
Nearest notices by article body length (1,419 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 25, 2026.
Frequently Asked Questions
Common questions about this FDA recall.