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, 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.  

We kindly request customers and partners to report any complaints or incidents, including any rupture or burst events, to their local Erbe representative or please contact our customer hotline at telephone number +49 7071 755-437, fax +49 7071 755-5437 or e-mail at techservice@erbegroup.com. 

We are in contact with the relevant regulatory authorities and are committed to transparent and timely communication with authorities, customers, and partners throughout this process. 

We sincerely regret any inconvenience this situation may cause. The safety of patients and users remains our highest priority.