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: 04050147021822/ Lots: WO459860 WO462187 WO462322 WO462390 WO462391 WO462392 WO462393 WO462396 WO462677 WO462678 WO463323 WO463324 WO463325 WO463326 WO463386 WO463387 WO464280 WO464281 WO464282 WO464283 WO464284 WO465059 WO465060 WO465061 WO465062 WO467876 WO467877 WO467878 WO467879 WO468225 WO468226 WO468227 WO468642 WO468643 WO468644 WO468645 WO468647 WO468671 WO468672 WO468673 WO468674 WO469361 WO469362 WO469363 W2459858 W2459958 W2462283 W2463593 W2465596 W2465623 W2465693 W2465768 W2468859 W2470050 W2470051 W2470052 W4465597
- 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
Flexible cryoprobes are used in cryoablation procedures to freeze tissue. They come in various diameters and lengths and are designed for surgical use by trained professionals.
Why This Is Dangerous
If activated, the probe may rupture or burst, which can cause tissue damage or procedural complications requiring clinical intervention.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals may need to halt procedures, replace affected probes, and manage recall communications with surgical teams and procurement.
Practical Guidance
How to identify if yours is affected
- Verify OD 1.7 mm and length 1.15 mm on the device
- Cross-check UDI 04050147021822 or listed lots
Where to find product info
Recall notices and guidance are available through the FDA enforcement page and the manufacturer’s recall communications.
What timeline to expect
Refunds or replacements typically take weeks to process once the manufacturer issues the remedy.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File a complaint with the FDA if the manufacturer is unresponsive
- Keep records of all communications
How to prevent similar issues
- Verify recalls before using surgical instruments
- Purchase from approved suppliers and maintain recall monitoring
- Implement device-tracking procedures for batch/lot numbers
Documentation advice
Keep the recall notice, batch/UDI numbers, correspondence with the manufacturer, and any replacement receipts or confirmations.
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Product Details
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.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Probes may rupture during activation
- Distributed nationwide in the US and Puerto Rico
- ACTIVE recall with notification by email
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Safety Guide
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