{"recall":{"id":"fda-device-99655","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Stryker Sustainability Solutions recalls BARD EP XT DECAPOLAR STEERABLE","firm":"Stryker Sustainability Solutions","date":"2026-08-18","reported":"2026-10-14","status":"Ongoing","classification":"Class II","products":[{"name":"BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007","code":"UDI-DI: 00885825003838. Lot: 5640704, Serial: 5097742, Distribution Date: May 26th 2026","quantity":"10","number":"Z-0085-2027","classification":"Class II"}],"reason":"Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the state of NJ.","nationwide":true,"states":[],"units":"10","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=99655","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"db1c384f71440937","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=99655","record":[{"status":"Ongoing","city":"Tempe","state":"AZ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99655","recalling_firm":"Stryker Sustainability Solutions","address_1":"1810 W Drake Dr","address_2":"N/A","postal_code":"85283-4327","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the state of NJ.","recall_number":"Z-0085-2027","product_description":"BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007","product_quantity":"10","reason_for_recall":"Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.","recall_initiation_date":"20260818","center_classification_date":"20261005","report_date":"20261014","code_info":"UDI-DI: 00885825003838. Lot: 5640704, Serial: 5097742, Distribution Date: May 26th 2026"}]}}