{"recall":{"id":"fda-device-99664","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"PI CARDIA LTD recalls Pi-Cardia Inc","firm":"PI CARDIA LTD","date":"2026-07-06","reported":"2026-09-23","status":"Ongoing","classification":"Class II","products":[{"name":"Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US","code":"UDI-DI - (01)7290020101242 All serial numbers in the affected lot SCUS-00013: SC919, SC920, SC921, SC923, SC924, SC925, SC926, SC927, SC928, SC929, SC930, SC931, SC932, SC933, SC934, SC935, SC936, SC937, SC938, SC939, SC940, SC941, SC942, SC943, SC944, SC945, SC946, SC947, SC948, SC949, SC950, SC951, SC952, SC953, SC954, SC956, SC957, SC958, SC960, SC961, SC962, SC963, SC964, SC966, SC967 and SC968.","quantity":"46 units","number":"Z-3213-2026","classification":"Class II"}],"reason":"Transfemoral catheter, positing arm may detached due to weld issue.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.","nationwide":true,"states":[],"units":"46 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=99664","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"d6344e015d8ed34d","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=99664","record":[{"status":"Ongoing","city":"Rehovot","state":"N/A","country":"Israel","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99664","recalling_firm":"PI CARDIA LTD","address_1":"5, David Pikes St","address_2":"N/A","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.","recall_number":"Z-3213-2026","product_description":"Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US","product_quantity":"46 units","reason_for_recall":"Transfemoral catheter, positing arm may detached due to weld issue.","recall_initiation_date":"20260706","center_classification_date":"20260917","report_date":"20260923","code_info":"UDI-DI - (01)7290020101242 All serial numbers in the affected lot SCUS-00013: SC919, SC920, SC921, SC923, SC924, SC925, SC926, SC927, SC928, SC929, SC930, SC931, SC932, SC933, SC934, SC935, SC936, SC937, SC938, SC939, SC940, SC941, SC942, SC943, SC944, SC945, SC946, SC947, SC948, SC949, SC950, SC951, SC952, SC953, SC954, SC956, SC957, SC958, SC960, SC961, SC962, SC963, SC964, SC966, SC967 and SC968.","more_code_info":""}]}}