The U.S. Food and Drug Administration (FDA) has issued an update to its recall of certain Erbe Flexible Cryoprobes, now including additional affected lot numbers. This recall, identified by the FDA as the most serious type, indicates that continued use of the device without correction may lead to serious injury or death.
Erbe USA reported these additional affected lot numbers on May 4, prompting the FDA's updated communication. The recommendations for handling the recalled devices have not changed since the initial announcement.
"This recall involves removing certain devices from where they are used or sold," the FDA said. Customers in the U.S. with adverse reactions, quality problems, or questions regarding this recall should contact Erbe USA directly at 770-955-4400.