{"recall":{"id":"fda-device-99122","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Medline Industries, LP recalls Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no","firm":"Medline Industries, LP","date":"2026-05-15","reported":"2026-07-08","status":"Ongoing","classification":"Class I","products":[{"name":"Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response\" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response\" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.","code":"Lot EP250203 Item no. 401206RH - UDI-DI 10197344043767; Item no. 401305RH - UDI-DI 10197344043637.","quantity":"3","number":"Z-2615-2026","classification":"Class I"}],"reason":"Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"US Nationwide distribution in the state of TX.","nationwide":true,"states":[],"units":"3","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=99122","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"fa6f317d7f17e856","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=99122","record":[{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99122","recalling_firm":"Medline Industries, LP","address_1":"3 Lakes Dr","address_2":"N/A","postal_code":"60093-2753","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the state of TX.","recall_number":"Z-2615-2026","product_description":"Reprocessed Electrophysiology Catheters and Ultrasound Catheters    Item no. 401206RH,\tSt. Jude Medical Response\" Diagnostic Electrophysiology Catheter 4 Elec. 10mm;    Item no. 401305RH,\tSt. Jude Medical Response\" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.","product_quantity":"3","reason_for_recall":"Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.","recall_initiation_date":"20260515","center_classification_date":"20260702","report_date":"20260708","code_info":"Lot EP250203  Item no. 401206RH - UDI-DI 10197344043767; Item no. 401305RH - UDI-DI 10197344043637."}]}}