Reported Aug 19, 2026 · Ongoing · Updated Sep 16, 2026
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Erbe USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Erbe USA Inc · 2225 Northwest Pkwy SE · Marietta, GA · 30067-8764
Is this the product you have?
- ERBECRYO 2
- Cryosurgical Unit Model/Catalog Number10402-000
- Lot codes and dates
- UDI-DI 04050147013797/ Serial NumbersAll serial
- numbers up to 11608268 Software Version1.0.3
- Amount recalled
- 1126 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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