Erbe Flexible Cryoprobe Recall: Probes May 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 is recalling flexible cryoprobes that may rupture or burst during activation. This could lead to serious injury or equipment failure during surgical procedures.

Why it’s dangerous

The cryoprobes may rupture or burst when activated, potentially causing injury to the patient or damage to surgical equipment. This hazard occurs during normal surgical use.

Who’s affected

Surgical professionals using the recalled cryoprobes for procedures. Patients undergoing surgery with these devices are at risk if the probe ruptures.

How to tell if you have this one

Check for the product name 'Flexible Cryoprobe' with specific dimensions (OD 1.1mm, L1.15mm) and oversheath (OD2.6mm, L817mm). Affected units have UDI: 04050147021785 and specific lot numbers listed in the recall.

Brand
Erbe
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the unique device identifier (UDI) 04050147021785 and the listed lot numbers to confirm if your cryoprobes are affected.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The cryoprobes may rupture or burst during activation, which could cause serious injury or equipment damage during surgical procedures.

How can I tell if my cryoprobes are affected?

Check for the UDI 04050147021785 and the specific lot numbers listed in the recall notice.

What should I do if I have the affected cryoprobes?

The recall does not specify a remedy, so contact Erbe USA Inc directly for guidance on next steps.

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-1566-2026 — Erbe Erbe

Hello,

I own a Erbe that is covered by recall Z-1566-2026 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-1566-2026 (February 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1566-2026 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 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use

Use caution until it’s fixed