Erbe USA recalled 5,154 Flexible Cryoprobes used in surgery after probes may rupture during activation. The defect can cause rupture or burst during activation. Stop using the device and follow recall instructions from the manufacturer.
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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Brand: Erbe USA. Product: Flexible Cryoprobe, OD 1.7 mm, L 1.15 mm. Reference: 20402-410. Units recalled: 5,154. Distribution: US nationwide including Puerto Rico. Recall date: 2026-02-12. Status: ACTIVE. Price: Not disclosed.
Probes may rupture or burst during activation in a surgical setting. This can disrupt procedures and pose a risk to patients.
No injuries or incidents have been reported.
1. Stop using the product. 2. Contact Erbe USA Inc or your healthcare provider for instructions. 3. Follow the manufacturer’s recall instructions. 4. Monitor for recall updates and guidance from healthcare facilities.
Recall notification is by email. Visit the FDA enforcement page at the provided recall link for official instructions. Manufacturer: Erbe USA Inc.
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