Erbe USA Inc: Unit, Cryosurgical, Accessories
Recall Summary Erbe USA Inc is recalling the ERBECRYO 2 Cryosurgical Unit (Model 10402-000) because pulling forcefully on the high-pressure transfer hose can cause a gas leak that builds up excessive pressure inside the device, potentially rupturing the cryoprobe. The affected units were distributed nationwide across all U.S. states and territories.
- Recalling firm
- Erbe USA Inc
- Product
- ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-26
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution including in the states and territories of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f8801af1-5f22-4220-8a47-dfbb278fb931