ERBECRYO 2 Cryosurgical Unit Model/Catalog Number recall
Erbe USA Inc recalled ERBECRYO 2 Cryosurgical Unit Model/Catalog Number on August 19, 2026 because of 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. It was sold nationwide.
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.
What's recalled
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Quantity: 1126 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Erbe USA Inc, Marietta, GA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
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, Michiga… - Status
- Ongoing
- Recall number
- Z-2938-2026
- Source
- U.S. Food and Drug Administration
More medical devices recalls
· Olympus Corporation of the AmericasMedline convenience kits containing Healthmark Instrument Channel Brushes
· Medline Industries, LPMidmark IQvitals Zone
· Midmark CorporationAchieva 3.0T; Model Numbers (REF)
· Philips North America LlcAutomated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1
· Abiomed, Inc.INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set
· CooperSurgical, Inc.