“Erbe has initiated a voluntary recall of specific flexible Cryoprobes (being produced from 21.07.2025 and before 14.11.2025) from the market. At the time of this letter [February 12, 2026], Erbe received 43 complaints related to this product problem. The 43 complaints have been identified as adverse events. The concerned lot numbers consist of a total quantity of 90,034 units. All affected customers will be directly informed.
We have been made aware of isolated cases in which certain flexible Cryoprobes ruptured during activation. In these cases, the rupture causes a loud sound. This could potentially lead to tinnitus, temporary hearing impairment, or in rare cases persistent hearing loss. Other potential injuries could include physical injuries from the burst, such as hand injuries and potential minor burns.
Our investigation determined that the rupture is caused by insufficient adhesive application during production, which can lead to excessive input pressure. This rupture has only been reported on the outer white tube, the part which is proximal to the scope. Following a comprehensive review, we concluded that this reported failure mode has occurred in less than 0.1% of Cryoprobes manufactured during the identified timeframe.
Although the incidence rate is very low, we have decided to voluntarily remove potentially affected products from the market as a precautionary measure.
Corrective actions have already been implemented. We have further improved and stabilized the manufacturing process and introduced additional inspection controls to ensure that all product specifications are consistently met.”
Flexible Cryoprobes
Flexible Cryoprobes are intended for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies.
The FDA is aware that Erbe USA had issued the letter dated February 12, 2026 to affected customers recommending certain Erbe Flexible Cryprobes be removed from where they are used or sold: as of February 24, Erbe USA has reported five serious injuries, and no deaths associated with this issue.
As a family-owned and operated business, Erbe develops, manufactures and markets surgical systems for professional use in various medical disciplines all over the world. It’s U.S. headquarters is located in Marietta, Georgia and it has about 115 employees.
“We provide our users with medical devices that they can truly rely on. That’s because our products are subject to rigorous continuous testing and meet highest quality standards. The superiority in performance and exceptional value offered by us optimizes safety during all types of medical procedures.”
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