Erbe USA recalled 2,408 Flexible Cryoprobes (REF 20402-411) used in surgery nationwide, including Puerto Rico. Probes may rupture or burst during activation. Hospitals and healthcare providers should stop using the device and follow recall instructions. Manufacturer contact will provide remediation.
Probes may rupture/burst during activation
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Erbe USA Inc or your healthcare provider for instructions. Notification method: E-Mail
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This device is a flexible cryoprobe used during surgical procedures to apply cold therapy at targeted sites.
The probe can rupture or burst during activation, presenting a safety risk during surgical use. The recall is intended to prevent patient harm and device failure during procedures.
This recall is not described as part of a broader industry pattern.
2,408 units distributed nationwide in the US and Puerto Rico. Immediate action requested for healthcare facilities.
FDA Enforcement Report for recall Z-1568-2026. https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1568-2026
Refund or replacement processing typically 4-8 weeks
Keep the recall notice, all correspondence with the manufacturer, device labels, packaging, and photos of the device for records
Model/ref: 20402-411. Distribution: US nationwide, including Puerto Rico. Quantity: 2,408 units. Sold to healthcare facilities. Recall date: 2026-02-12. Status: ACTIVE. Manufacturer: Erbe USA Inc. UDI: 04050147021846. Lots: WO461840, WO461846, WO462097, W2462284, WO463327, WO463328, WO463388, W2463594, WO464285, WO464286, WO465063, WO465064, W4465351, W2465601, W2465689, W2465749, W2465769, WO467873, WO467874, WO467875, WO468648, WO468649, WO469364, W2459861, W2459862, W2459863.
No injuries or incidents have been reported.
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