{"recall":{"id":"fda-device-99586","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Karl Storz Endoscopy recalls HOPKINS Telescope 30¿","firm":"Karl Storz Endoscopy","date":"2026-08-12","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for visualization of the surgical site during diagnostic and therapeutic endoscopic procedures.","code":"Material Number: 10005BA UDI-DI code: 04048551045121 Serial Numbers: 100011, 100012, 10000Y, and 10000Z","quantity":"6 eyepieces","number":"Z-3333-2026","classification":"Class II"}],"reason":"Due to incorrect inside packaging label for eyepiece.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S. Nationwide distribution in the states of AZ, CA and MO.","nationwide":true,"states":[],"units":"6 eyepieces","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=99586","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"0de96f16f8f26921","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=99586","record":[{"status":"Ongoing","city":"El Segundo","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99586","recalling_firm":"Karl Storz Endoscopy","address_1":"2151 E Grand Ave","address_2":"","postal_code":"90245-5017","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"U.S. Nationwide distribution in the states of AZ, CA and MO.","recall_number":"Z-3333-2026","product_description":"HOPKINS Telescope 30¿, 4mm REF 10005BA  UDI-DI code: 04048551045121    KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for visualization of the surgical site during diagnostic and therapeutic endoscopic procedures.","product_quantity":"6 eyepieces","reason_for_recall":"Due to incorrect inside packaging label for eyepiece.","recall_initiation_date":"20260812","center_classification_date":"20260930","report_date":"20261007","code_info":"Material Number: 10005BA UDI-DI code: 04048551045121 Serial Numbers: 100011, 100012, 10000Y, and 10000Z","more_code_info":""}]}}