Erbe USA Inc recalls ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- ERBECRYO 2 Cryosurgical Unit Model/Catalog Number:10402-000UDI-DI 04050147013797/2 affected lots116082681.0.3
What the firm is doing
On June 26, 2026, Erbe USA issued a Urgent: Medical Device Correction update notification to affected consignees via multiple methods ( Email/Website/Hand delivery). ERBE ask consignees to take the following actions: 1. We request the ERBECRYO 2 Unit be made available to the Erbe Representative to install the (V)1.0.4 Software. The Erbe Representative will perform all tasks required to update the software. 2. Confirm acknowledgement with Erbe Representative on-site. 3. Share this notice with all users within your facility. 4.While awaiting software update, there is no change of the Cryosurgical Unit s intended use or performance. Please continue to follow all warnings, instructions, guidelines, etc. involved with the Unit and Cryoprobe.
DistributionShow detailsHide
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, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2938-2026
- FDA 510(k) clearance · K190651The device's official FDA premarket clearance record
- FDA device classification · GEHOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4350The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Erbe USA IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) BASIC PACK
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Eye Tray
- Nonconforming Material/Component
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Orthopedic Tray
- Nonconforming Material/Component
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Neurological Tray
- Nonconforming Material/Component