Erbe Flexible Cryoprobe Recall: Risk of Rupture During Activation

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Recalling firmErbe USA Inc2225 Northwest Pkwy SE · Marietta, GA 30067-8764

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Erbe recalls certain flexible cryoprobes used in surgery because they may rupture or burst when activated. This could lead to serious injury if the device fails during use.

Why it’s dangerous

The cryoprobes may rupture or burst when activated, potentially causing injury to the user or patient. This hazard occurs during normal surgical use when the device is being activated.

Who’s affected

Surgical professionals and hospitals that use the recalled cryoprobes are most at risk. Patients undergoing procedures with these devices could be affected if the probe ruptures.

How to tell if you have this one

Check for the model number OD 2.4mm, L1.15mm and reference number 20402-411. Affected units include specific lots and serial numbers listed in the recall notice.

Brand
Erbe
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Identify the model number (OD 2.4mm, L1.15mm) and reference number (20402-411) on the device.
Contact Manufacturer
Reach out to Erbe USA for specific instructions on how to handle the recalled units.

✎ GovInfoNow

Questions people ask

Why is this cryoprobes being recalled?

The cryoprobes may rupture or burst during activation, which could cause serious injury.

What should I do if I have this device?

Check the device details and contact Erbe USA for specific instructions on handling the recalled units.

Are there any specific lots or serial numbers affected?

Yes, specific lots and serial numbers are listed in the recall notice, including expanded lots and initial lots.

Take action

Contact Erbe

We’ve drafted a message you can send Erbe to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1568-2026 — Erbe Erbe

Hello,

I own a Erbe that is covered by recall Z-1568-2026 from Erbe.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1568-2026 (February 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1568-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Erbe USA Inc recalls Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use

Use caution until it’s fixed