FDA Expands ERBECRYO 2 Cryosurgical Unit Recall Over Probe Rupture Risk
The FDA has expanded a recall of ERBECRYO 2 cryosurgical units to include additional serial numbers, citing a risk that the attached cryoprobe can rupture.
4 reports on this incident · first at Aug 27, 2026, 8:35 a.m. ET
Earlier reports
Aug 27, 2026, 8:46 a.m. ET
FDA Reclassifies ERBECRYO 2 Cryosurgical Unit Recall as Class II
The U.S. Food and Drug Administration has reclassified the recall of ERBECRYO 2 cryosurgical units, model 10402-000, as Class II, according to an FDA enforcement report dated August 19, 2026. The agency defines Class II as its middle category, used where the product may cause temporary or medically reversible harm and where the chance of serious harm is remote.
The correction, initiated June 26, 2026, covers 11,226 units distributed across all 50 states, the District of Columbia, and Puerto Rico. The FDA record lists no reported injuries. The reason for the correction is that a strong pull on the high-pressure transfer hose can create what Erbe USA calls a pneumatic short circuit between the gas inlet and the connector, which can cause the attached cryoprobe to rupture. The remedy is for Erbe representatives to install updated software.
Affected units carry serial numbers up to 11608268 and software version 1.0.3. The recall status is listed as open. The FDA database records no other enforcement action by Erbe USA.
Aug 27, 2026, 8:40 a.m. ET
FDA Reports Injuries in ERBECRYO 2 Cryosurgical Unit Recall
The U.S. Food and Drug Administration (FDA) has reported injuries in connection with the recall of ERBECRYO 2 cryosurgical units, model 10402-000, according to the agency's enforcement report. The FDA record for this correction, which previously listed no injuries, now includes reported injuries, though the agency does not specify their nature or severity. The recall, initiated June 26, 2026, and reported August 19, 2026, covers 11,226 units distributed across all 50 states, the District of Columbia, and Puerto Rico.
The FDA classified the action as Class II, its middle category, used when a product may cause temporary or medically reversible harm and the chance of serious harm is remote. The recall was prompted by a risk that the attached cryoprobe can rupture if a strong pull on the high-pressure transfer hose creates what the company calls a pneumatic short circuit between the gas inlet and the connector. Erbe USA, based in Marietta, GA, is correcting the issue by having representatives install updated software on affected units, identified by serial numbers up to 11608268 and software version 1.0.3.
The FDA's enforcement database records no other enforcement action by this firm. The recall remains open, and the agency's report does not specify the number or details of the reported injuries.
Aug 27, 2026, 8:35 a.m. ETFirst report
FDA Closes Recall of ERBECRYO 2 Cryosurgical Units Over Probe Rupture Risk
The U.S. Food and Drug Administration (FDA) has closed the recall of ERBECRYO 2 cryosurgical units, model 10402-000, according to an enforcement report dated August 19, 2026. The agency considers the correction complete, meaning the recall has been carried out.
The Class II recall, initiated June 26, 2026, covers 11,226 units with serial numbers up to 11608268 and software version 1.0.3. The FDA's middle classification indicates the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
The action was prompted by a risk that the attached cryoprobe can rupture if a strong pull on the high-pressure transfer hose creates a pneumatic short circuit between the gas inlet and the connector. The remedy involved Erbe representatives installing updated software. The FDA record lists no reported injuries.
The units were distributed nationwide, including all 50 states, the District of Columbia, and Puerto Rico. The FDA database records no other enforcement action by Erbe USA, based in Marietta, GA.
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