Erbe recalls ERBECRYO 2 Cryosurgical Units with serial numbers up to 11608268. A strong pull on the transfer hose may cause CO2 leakage and cryoprobe rupture.
A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture.
Erbe is recalling its ERBECRYO 2 cryosurgical units with specific serial numbers due to a risk of cryoprobe rupture from CO2 leakage. This could happen if the high-pressure transfer hose is pulled, potentially causing serious injury during surgery.
A strong pull on the high-pressure transfer hose can cause a pneumatic short circuit. This leads to CO2 leaking into the return path, which may cause excessive pressure and rupture of the cryoprobe during use.
Medical professionals using the ERBECRYO 2 cryosurgical units with serial numbers up to 11608268 are affected. Surgeons and medical staff performing cryosurgery are most at risk.
Check the serial number on the unit, which should be up to 11608268. The product was sold with software version 1.0.3 and model number 10402-000.
Identify the serial number on your ERBECRYO 2 cryosurgical unit to confirm if it falls within the recall range (up to 11608268).
Contact Erbe USA Inc for further instructions on the recall process.
The model number is 10402-000.
A strong pull on the high-pressure transfer hose may cause CO2 leakage and cryoprobe rupture, potentially leading to serious injury.
Check the serial number on your unit; affected units have serial numbers up to 11608268.
We’ve drafted a message you can send Erbe to request your refund or repair — edit it as you like.
Subject: Recall Z-2938-2026 — Erbe Erbe Hello, I own a Erbe that is covered by recall Z-2938-2026 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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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.