{"recall":{"id":"fda-device-99259","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Maquet Cardiovascular, LLC recalls The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000","firm":"Maquet Cardiovascular, LLC","date":"2026-06-02","reported":"2026-07-22","status":"Ongoing","classification":"Class II","products":[{"name":"The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.","code":"UDI 00607567700406, Serial/Lot Number 3000547797","quantity":"205 units","number":"Z-2741-2026","classification":"Class II"}],"reason":"Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.","nationwide":true,"states":[],"units":"205 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=99259","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"292c3cf865fec177","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=99259","record":[{"status":"Ongoing","city":"Wayne","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99259","recalling_firm":"Maquet Cardiovascular, LLC","address_1":"45 Barbour Pond Dr","address_2":"","postal_code":"07470-2094","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Telephone","distribution_pattern":"US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.","recall_number":"Z-2741-2026","product_description":"The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI  00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.","product_quantity":"205 units","reason_for_recall":"Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.","recall_initiation_date":"20260602","center_classification_date":"20260715","report_date":"20260722","code_info":"UDI 00607567700406, Serial/Lot Number 3000547797","more_code_info":""}]}}