{"recall":{"id":"fda-device-99333","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Argon Medical Devices, Inc recalls 2 products","firm":"Argon Medical Devices, Inc","date":"2026-06-15","reported":"2026-08-05","status":"Ongoing","classification":"Class II","products":[{"name":"L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60cm, REF: 384464; Basic Kit 28GA (1.2F) x 25cm 1 Lumen), REF: 384516; 20ga (3F) 1.00mm x 60cm, REF: 384463","code":"REF/UDI-DI/Lot(Expiration): 384539/00886333209934/11488167(7/14/2026), 11488168(7/17/2026), 11494535E(8/1/2026), 11507766(11/13/2026), 11550780(12/12/2026), 11551487(12/15/2026), 11551488(12/15/2026); 384464/00886333209835/11490593(7/28/2026), 11494886(8/28/2026)11501150(10/6/2026); 384516/00886333209910/11500410(8/14/2026), 11501856(8/14/2026), 11504222(9/9/2026), 11506952(9/9/2026), 11523868(9/18/2026), 11551789(9/18/2026), 11553909(11/13/2026), 11559226(11/20/2026); 384463/00886333209828/11490797(8/1/2026), 11490959(8/11/2026)","quantity":"6928","number":"Z-2803-2026","classification":"Class II"},{"name":"L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620","code":"REF/UDI-DI/Lot(Expiration): 384620/00886333210008/11490543(7/28/2026)","quantity":"20","number":"Z-2804-2026","classification":"Class II"}],"reason":"Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US: AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OR, TN, TX, UT, VA, WA.  OUS: MYS, CAN, SAU","nationwide":false,"states":["AR","CA","CO","CT","FL","GA","IA","ID","IL","IN","KS","MA","MD","MI","MN","MO","MS","NC","ND","NJ","NV","NY","OR","TN","TX","UT","VA","WA"],"units":"6928; 20","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=99333","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"691ed2607dee11dc","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=99333","record":[{"status":"Ongoing","city":"Athens","state":"TX","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99333","recalling_firm":"Argon Medical Devices, Inc","address_1":"1445 Flat Creek Rd","address_2":"N/A","postal_code":"75751-5002","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US: AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OR, TN, TX, UT, VA, WA.  OUS: MYS, CAN, SAU","recall_number":"Z-2803-2026","product_description":"L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60cm, REF: 384464; Basic Kit 28GA (1.2F) x 25cm 1 Lumen), REF: 384516; 20ga (3F) 1.00mm x 60cm, REF: 384463","product_quantity":"6928","reason_for_recall":"Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.","recall_initiation_date":"20260615","center_classification_date":"20260724","report_date":"20260805","code_info":"REF/UDI-DI/Lot(Expiration): 384539/00886333209934/11488167(7/14/2026), 11488168(7/17/2026), 11494535E(8/1/2026), 11507766(11/13/2026), 11550780(12/12/2026), 11551487(12/15/2026), 11551488(12/15/2026);  384464/00886333209835/11490593(7/28/2026), 11494886(8/28/2026)11501150(10/6/2026);  384516/00886333209910/11500410(8/14/2026), 11501856(8/14/2026), 11504222(9/9/2026), 11506952(9/9/2026), 11523868(9/18/2026), 11551789(9/18/2026), 11553909(11/13/2026), 11559226(11/20/2026);  384463/00886333209828/11490797(8/1/2026), 11490959(8/11/2026)"},{"status":"Ongoing","city":"Athens","state":"TX","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99333","recalling_firm":"Argon Medical Devices, Inc","address_1":"1445 Flat Creek Rd","address_2":"N/A","postal_code":"75751-5002","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US: AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OR, TN, TX, UT, VA, WA.  OUS: MYS, CAN, SAU","recall_number":"Z-2804-2026","product_description":"L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620","product_quantity":"20","reason_for_recall":"Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.","recall_initiation_date":"20260615","center_classification_date":"20260724","report_date":"20260805","code_info":"REF/UDI-DI/Lot(Expiration): 384620/00886333210008/11490543(7/28/2026)"}]}}