{"recall":{"id":"fda-device-99106","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Olympus Corporation of the Americas recalls Olympus Single Use Distal Cover","firm":"Olympus Corporation of the Americas","date":"2026-06-05","reported":"2026-07-15","status":"Ongoing","classification":"Class II","products":[{"name":"Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid","code":"UDI/DI: 04953170441271, Lot Numbers: H2530 or later","quantity":"988700 units","number":"Z-2676-2026","classification":"Class II"}],"reason":"Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution.","nationwide":true,"states":[],"units":"988700 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=99106","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"d099220ee5f692ce","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=99106","record":[{"status":"Ongoing","city":"Center Valley","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99106","recalling_firm":"Olympus Corporation of the Americas","address_1":"3500 Corporate Pkwy","address_2":"N/A","postal_code":"18034-8229","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-2676-2026","product_description":"Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid","product_quantity":"988700 units","reason_for_recall":"Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.","recall_initiation_date":"20260605","center_classification_date":"20260707","report_date":"20260715","code_info":"UDI/DI: 04953170441271, Lot Numbers: H2530 or later"}]}}