Quick Facts at a Glance
- Recall Date
- February 12, 2026
- Hazard Level
- HIGH
- Brand
- Erbe USA
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Erbe USA
- Product type
- Flexible Cryoprobe
- Model numbers
- 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
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 12, 2026
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Probes may rupture/burst during activation
What You Should Do
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
About This Product
This device is a flexible cryoprobe used during surgical procedures to apply cold therapy at targeted sites.
Why This Is Dangerous
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.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
2,408 units distributed nationwide in the US and Puerto Rico. Immediate action requested for healthcare facilities.
Practical Guidance
How to identify if yours is affected
- Verify REF 20402-411 on the device label
- If any match, stop using the device and follow recall instructions
Where to find product info
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
What timeline to expect
Refund or replacement processing typically 4-8 weeks
If the manufacturer is unresponsive
- Escalate with your hospital risk management team
- File a consumer complaint with the FDA if the manufacturer is unresponsive
- Document all communications for records
How to prevent similar issues
- Verify device recalls before purchasing surgical probes
- Ask suppliers for current recall status and serial numbers
- Maintain a recall log for devices and lot numbers
- Follow manufacturer recommendations for device retirement and disposal
Documentation advice
Keep the recall notice, all correspondence with the manufacturer, device labels, packaging, and photos of the device for records
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Reported Incidents
No injuries or incidents have been reported.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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