{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221364", "product_res_number": "Z-2938-2026", "event_date_initiated": "2026-06-26", "event_date_posted": "2026-08-12", "recall_status": "Open, Classified", "res_event_number": "99341", "product_code": "GEH", "k_numbers": [ "K190651" ], "product_description": "ERBECRYO 2 Cryosurgical Unit\nModel/Catalog Number: 10402-000", "code_info": "UDI-DI 04050147013797/ \nSerial Numbers: All serial numbers up to 11608268\nSoftware Version: 1.0.3", "firm_fei_number": "1000140388", "recalling_firm": "Erbe USA Inc", "address_1": "2225 Northwest Pkwy SE", "city": "Marietta", "state": "GA", "postal_code": "30067-8764", "additional_info_contact": "Customer Service \n770-955-4400 Ext. 133", "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.", "root_cause_description": "Device Design", "action": "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: \n\n1. 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.\n2. Confirm acknowledgement with Erbe Representative on-site.\n3. Share this notice with all users within your facility.\n4.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.", "product_quantity": "11226 units", "distribution_pattern": "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.", "openfda": { "k_number": [ "K152133", "K021387", "K234002", "K150920", "K871314", "K140314", "K012497", "K183213", "K173037", "K832334", "K101333", "K161480", "K110754", "K161294", "K152668", 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