HIGH

Erbe USA Recalls 5,154 Flexible Cryoprobes for Surgical Use Over Rupture Risk (2026)

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.

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

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

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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

  1. Verify OD 1.7 mm and length 1.15 mm on the device
  2. Check REF 20402-410
  3. 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.

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

  • 5,154 units recalled
  • Probes may rupture during activation
  • Distributed nationwide in the US and Puerto Rico
  • Recall initiated 2026-02-12
  • ACTIVE recall with notification by email

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
LACERATIONOTHER

Product Details

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
Affected States
ALL
Report Date
April 1, 2026
Recall Status
ACTIVE

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