Recall Z-1568-2026

Reason for recall

Probes may rupture/burst during activation

FDA-determined cause: Process control

Action taken

On May 5, 2026, ERBE USA issued a "Urgent Medical Device Recall Expansion notification via E-Mail. The expansion was issued due to new lot numbers that may cause the same failure mode. The original notification was issued on Feb. 12, 2026. ERBE asked consignees to take the following actions: 1. Discontinue use of the products with the affected lot numbers. 2. Examine your inventory, remove, and quarantine any identified devices with the affected lot numbers 3. Ensure all applicable personnel within the vicinity of device activation carefully read the content of this notification. If affected product has been transferred to a different location, please ensure that location and personnel receive a copy of this notification. 4. Please contact Erbe at fieldaction.us@erbegroup.com or 678-483-8499, to obtain a Return Material Authorization number 5. Please complete the Response Form and return to Erbe 6. If you have further distributed this product, identify your locations, and forward this notification to them. 7. Erbe requests you to report any complaints, including any instances of ruptures/bursts, to our Technical Service Department at 770-955-4400. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program.