{"recall":{"id":"fda-device-99341","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Erbe USA Inc recalls ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000","firm":"Erbe USA Inc","date":"2026-06-26","reported":"2026-08-19","status":"Ongoing","classification":"Class II","products":[{"name":"ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000","code":"UDI-DI 04050147013797/ Serial Numbers: All serial numbers up to 11608268 Software Version: 1.0.3","quantity":"1126 units","number":"Z-2938-2026","classification":"Class II"}],"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"1126 units","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99341","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"8895340d6bcaf605","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99341","record":[{"status":"Ongoing","city":"Marietta","state":"GA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99341","recalling_firm":"Erbe USA Inc","address_1":"2225 Northwest Pkwy SE","address_2":"","postal_code":"30067-8764","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","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.","recall_number":"Z-2938-2026","product_description":"ERBECRYO 2 Cryosurgical Unit  Model/Catalog Number: 10402-000","product_quantity":"1126 units","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.","recall_initiation_date":"20260626","center_classification_date":"20260812","report_date":"20260819","code_info":"UDI-DI 04050147013797/  Serial Numbers:  All serial numbers up to 11608268 Software Version: 1.0.3","more_code_info":""}]}}