{"recall":{"id":"fda-device-99069","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Argon Medical Devices, Inc recalls 6 products","firm":"Argon Medical Devices, Inc","date":"2026-06-01","reported":"2026-07-22","status":"Ongoing","classification":"Class I","products":[{"name":"Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A","code":"REF/UDI-DI Box:Unit/Lot(Expiration): 008416A/20886333217636:00886333217632/11656898(7/19/2027); 008566A/20886333217643:00886333217649/11654475(12/31/2026), 11654478(7/19/2027)","quantity":"950","number":"Z-2704-2026","classification":"Class I"},{"name":"One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular","code":"REF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027);","quantity":"200","number":"Z-2705-2026","classification":"Class I"},{"name":"General Biospy Tray, REF: GUTS1000","code":"REF/UDI-DI Box:Unit/Lot(Expiration): GUTS1000/20886333001594:00886333001590/11649760(3/31/2028)","quantity":"1800","number":"Z-2706-2026","classification":"Class I"},{"name":"T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL","code":"REF/UDI-DI Box:Unit/Lot(Expiration): BMT1104STL/20886333007862:00886333007868/11650679(11/30/2026); BMET1104TL/20886333007602:00886333007608/11654764(3/31/2028); BMT1104CATL/20886333007763:00886333007769/11650887(11/30/2026)","quantity":"850","number":"Z-2707-2026","classification":"Class I"},{"name":"Arterial Line Kit 20ga x 6, REF: 400115A","code":"REF/UDI-DI Box:Unit/Lot(Expiration): 400115A/20886333212884:00886333212880/11655174(7/19/2027), 11655183(7/19/2027), 11655185(7/19/2027), 11659131(7/19/2027);","quantity":"440","number":"Z-2708-2026","classification":"Class I"},{"name":"Bone Marrow Tray, REF: CB0033TL; CB0355TLA","code":"REF/UDI-DI Box:Unit/Lot(Expiration): CB0033TL/20886333217308:00886333217304/11650820(3/31/2028), 11652276(3/31/2028); CB0355TLA/20886333217698:00886333217694/11651977(3/31/2028);","quantity":"680","number":"Z-2709-2026","classification":"Class I"}],"reason":"Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.","nationwide":true,"states":[],"units":"950; 200; 1800; 850; 440; 680","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=99069","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"b475bf02c20839da","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=99069","record":[{"status":"Ongoing","city":"Athens","state":"TX","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99069","recalling_firm":"Argon Medical Devices, Inc","address_1":"1445 Flat Creek Rd","address_2":"","postal_code":"75751-5002","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.","recall_number":"Z-2704-2026","product_description":"Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A","product_quantity":"950","reason_for_recall":"Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.","recall_initiation_date":"20260601","center_classification_date":"20260710","report_date":"20260722","code_info":"REF/UDI-DI Box:Unit/Lot(Expiration): 008416A/20886333217636:00886333217632/11656898(7/19/2027);  008566A/20886333217643:00886333217649/11654475(12/31/2026), 11654478(7/19/2027)","more_code_info":""},{"status":"Ongoing","city":"Athens","state":"TX","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99069","recalling_firm":"Argon Medical Devices, Inc","address_1":"1445 Flat Creek Rd","address_2":"","postal_code":"75751-5002","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.","recall_number":"Z-2705-2026","product_description":"One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular","product_quantity":"200","reason_for_recall":"Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.","recall_initiation_date":"20260601","center_classification_date":"20260710","report_date":"20260722","code_info":"REF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027);  497455/20886333214635:00886333214631/11658984 (7/19/2027);","more_code_info":""},{"status":"Ongoing","city":"Athens","state":"TX","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99069","recalling_firm":"Argon Medical Devices, Inc","address_1":"1445 Flat Creek Rd","address_2":"","postal_code":"75751-5002","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.","recall_number":"Z-2706-2026","product_description":"General Biospy Tray, REF: GUTS1000","product_quantity":"1800","reason_for_recall":"Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.","recall_initiation_date":"20260601","center_classification_date":"20260710","report_date":"20260722","code_info":"REF/UDI-DI Box:Unit/Lot(Expiration): GUTS1000/20886333001594:00886333001590/11649760(3/31/2028)","more_code_info":""},{"status":"Ongoing","city":"Athens","state":"TX","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99069","recalling_firm":"Argon Medical Devices, Inc","address_1":"1445 Flat Creek Rd","address_2":"","postal_code":"75751-5002","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.","recall_number":"Z-2707-2026","product_description":"T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL","product_quantity":"850","reason_for_recall":"Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.","recall_initiation_date":"20260601","center_classification_date":"20260710","report_date":"20260722","code_info":"REF/UDI-DI Box:Unit/Lot(Expiration): BMT1104STL/20886333007862:00886333007868/11650679(11/30/2026); BMET1104TL/20886333007602:00886333007608/11654764(3/31/2028);  BMT1104CATL/20886333007763:00886333007769/11650887(11/30/2026)","more_code_info":""},{"status":"Ongoing","city":"Athens","state":"TX","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99069","recalling_firm":"Argon Medical Devices, Inc","address_1":"1445 Flat Creek Rd","address_2":"","postal_code":"75751-5002","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.","recall_number":"Z-2708-2026","product_description":"Arterial Line Kit 20ga x 6, REF: 400115A","product_quantity":"440","reason_for_recall":"Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.","recall_initiation_date":"20260601","center_classification_date":"20260710","report_date":"20260722","code_info":"REF/UDI-DI Box:Unit/Lot(Expiration): 400115A/20886333212884:00886333212880/11655174(7/19/2027), 11655183(7/19/2027), 11655185(7/19/2027), 11659131(7/19/2027);","more_code_info":""},{"status":"Ongoing","city":"Athens","state":"TX","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99069","recalling_firm":"Argon Medical Devices, Inc","address_1":"1445 Flat Creek Rd","address_2":"","postal_code":"75751-5002","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.","recall_number":"Z-2709-2026","product_description":"Bone Marrow Tray, REF: CB0033TL; CB0355TLA","product_quantity":"680","reason_for_recall":"Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.","recall_initiation_date":"20260601","center_classification_date":"20260710","report_date":"20260722","code_info":"REF/UDI-DI Box:Unit/Lot(Expiration): CB0033TL/20886333217308:00886333217304/11650820(3/31/2028), 11652276(3/31/2028);   CB0355TLA/20886333217698:00886333217694/11651977(3/31/2028);","more_code_info":""}]}}