{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 17 } }, "results": [ { "cfres_id": "219186", "product_res_number": "Z-1876-2026", "event_date_initiated": "2026-02-27", "event_date_posted": "2026-04-17", "recall_status": "Open, Classified", "res_event_number": "98601", "product_code": "OEQ", "product_description": "Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes \n\nJUDKINS PACK DYNJ51126\n\nANGIO PACK\tDYNJ32555C, DYNJ66631\n\t\nANGIO TRAY\tDYNJ46153B\n\t\nANGIOGRAPHY PACK\tDYNJ26855F\n\t\nANGIOGRAPHY PACK-M-LF\tDYNJ24530I\n\t\nANGIOGRAPHY TRAY-LF\tDYNJ0220880V, DYNJ30077D\n\t\nCATH LAB ANGIO PACK-LF\tDYNJ0545064X\n\t\nCATH LAB PACK\tDYNJ39057C\n\t\nFEMORAL ANGIOGRAPY SET UP\tDYNJ61015B\n\t\nRAD-ANGIO PACK\tDYNJ47710C\n\t\nSURGERY ANGIO PACK-LF\tPHS677784013A", "code_info": "DYNJ51126\nUDI-DI 10889942122820 (EA)\n40889942122821 (CS)\nLOT 20ADA585\n\nDYNJ32555C\t\nUDI-DI 10193489859485 (EA)\t40193489859486 (CS)\nLOTS \t21HMF699\n\t\t\t21IMF813\n\t\t\t21JMA855\n\t\t\t21KMD605\n\t\t\t22DMB423\n\t\t\t22FMD574\n\t\t\t22HMB608\n\t\t\t22LMA169\n\t\t\t23BMA114\n\t\t\t23EMB817\n\t\t\t23EMG153\n\t\t\t23KMB692\n\t\t\t23KMH359\n\t\t\t23LMH085\n\t\t\t24AMC563\n\t\t\t24CMD587\n\t\t\t24DMD256\n\t\t\t24DMG305\n\t\t\t24FMD717\n\t\t\t24IMI650\n\t\t\t24JMC830\n\t\t\t\nDYNJ66631\t\nUDI-DI 10193489368321 (EA)\t40193489368322 (CS)\nLOTS \t22BBB494\n\t\t\t22BBB497\n\t\t\t\nDYNJ46153B\t\nUDI-DI 10193489853643 (EA)\t40193489853644 (CS)\nLOTS \t23EBM225\n\t\t\t23FBC884\n\t\t\t23HBP278\n\t\t\t23IBV999\n\t\t\t23KBC319\n\t\t\t23LBK125\n\t\t\t24CBF100\n\t\t\t24DBE952\n\t\t\t24FBP262\n\t\t\t24GBN960\n\t\t\t24HBO921\n\t\t\t24IBO007\n\t\t\t24IBU941\n\t\t\t24JBK669\n\t\t\t24LBK644\n\t\t\t\nDYNJ26855F\t\nUDI-DI 10888277012042 (EA)\t40888277012043 (CS)\nLOTS \t20CBI049\n\t\t\t20EBB600\n\t\t\t20FBK900\n\t\t\t20GBD331\n\t\t\t20GBL795\n\t\t\t20IBC788\n\t\t\t20JBM786\n\t\t\t20KBF148\n\t\t\t21BBK244\n\t\t\t21EBR327\n\t\t\t21HBB849\n\t\t\t21IBQ809\n\t\t\t21OBA396\n\t\t\t\nDYNJ24530I\t\nUDI- DI 10193489674910 (EA)\t40193489674911 (CS)\t\nLOT 24ABU775\n\t\t\t\nDYNJ0220880V\t\nUDI-DI 10889942054688 (EA)\t40889942054689 (CS)\nLOTS \t23HLA505\n\t\t\t23HLB257\n\t\t\t23JLA021\n\t\t\t23JLA059\n\t\t\t23KLA121\n\t\t\t23KLA231\n\t\t\t23KLA582\n\t\t\t23LLA817\n\t\t\t24ELA405\n\t\t\t24ELA796\n\t\t\t24HLA596\n\t\t\t25AMI609\n\t\t\t25BMH660\n\t\t\t25CMA797\n\t\t\t25DMF893\n\t\t\t\nDYNJ30077D\t\nUDI-DI 10889942138630 (EA)\t40889942138631 (CS)\nLOTS \t23FBQ479\n\t\t\t23LBL707\n\t\t\t24CBC495\n\t\t\t24EBQ346\n\t\t\t24GBK895\n\t\t\t24HBD023\n\t\t\t24HBP290\n\t\t\t24JBJ112\n\t\t\t\nDYNJ0545064X\t\nUDI-DI 10193489747621 (EA)\t40193489747622 (CS)\nLOTS \t20BBL115\n\t\t\t20CBA649\n\t\t\t20DBB933\n\t\t\t20DBP595\n\t\t\t20HBW939\n\t\t\t20KBI815\n\t\t\t21ABK039\n\t\t\t21ABK542\n\t\t\t\nDYNJ39057C\t\nUDI-DI 10193489765519 (EA)\t40193489765510 (CS)\nLOT \t24BBD166\n\t\t\t\nDYNJ61015B\t\nUDI-DI 10193489368888 (EA)\t40193489368889 (CS)\nLOTS \t23CMG023\n\t\t\t23FBN151\n\t\t\t\nDYNJ47710C\t\nUDI-DI 10889942214495 (EA)\t40889942214496 (CS)\nLOTS \t23FBF109\n\t\t\t23GBB677\n\t\t\t23JBP270\n\t\t\t23LBO688\n\t\t\t24DBD356\n\t\t\t24FBP326\n\t\t\t24IBC340\n\t\t\t24KBJ788\n\t\t\t\nPHS677784013A\t\nUDI-DI 10193489604337 (EA)\t40193489604338 (CS)\nLOTS \t20BBR301\n\t\t\t20IMA683\n\t\t\t21BMC467\n\t\t\t21CMC052\n\t\t\t21FMD140\n\t\t\t21IMF229\n\t\t\t22AMA959\n\t\t\t22AME458\n\t\t\t23GMA491\n\t\t\t23GMD585\n\n***Updated 5/20/26 - The following lots were included in the customer notification but not in the FDA submission.***\n\nDYNJ0220880V\nLots\n21DLA453\n21FLA083\n21ILA147\n21KLA059\n22ALA849\n22DLA707\n22FLA700\n22HLA272\n22ILA188\n22ILA237\n22ILA641\n22JLA662\n22KLA836\n22KLA939\n22LLA399\n25KMB595\n25LMA384;\n\nDYNJ30077D\nLots\n21ABB348\n21ABR327\n21DBQ397\n21FBM873\n21GBL539\n21IBB390\n21JBO220\n21KBC302\n21KBV079\n21LBT528\n22ABZ834\n22DBD744\n22EBG375\n22JBK533\n22KBO291\n22OBM411\n23ABD824\n23ABO419\n23DBB788\n23EBS951\n23HBB563\n23IBG762\n23JBT149\n24CBR583;\n\nDYNJ32555C\nLots\n21DMA301\n21DMD929\n21EMB686\n21FMA163\n22KMD644\n23AMB073\n24LMH114\n25BMA103\n25BMD349;\n\nDYNJ46153B\nLots\n21CBL359\n21FBE618\n21GBF346\n21HBQ716\n21IBW154\n21KBI853\n21LBA401\n22ABE877\n22BBW978\n22CBU323\n22EBN725\n22FBQ420\n22GBJ229\n22HBD581\n22IBL258\n22JBM061\n22KBD440\n22NBA199\n23ABG769\n23BBE724\n25BBR850\n25EBA187;\n\nDYNJ47710C\nLots\n21CBM120\n21GBL622\n21KBA849\n21KBA925\n22ABX239\n22CBP654\n22JBI023\n22LBR933\n23BBT611\n25BBF414\n25CBJ501;\n\nDYNJ61015B\nLots\n21AMB131\n21BMB923\n21BMC128\n21CMD384\n21DMD441\n21FMD102\n21GME205\n21JMG652\n22AMD050\n22AME244\n22DME869\n22FMA872\n22FMD246\n22GMG534\n22IMB779\n22IMF574\n22JMG963\n23AMD815\n23BMB886\n23DMC707;\n\nDYNJ66631\nLots\n21IBH359\n21VBC892\n22BBW852\n22DBJ281\n22EBJ532\n22GBA380", "firm_fei_number": "1417592", "recalling_firm": "Medline Industries, LP", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Haley Barclay\n800-633-5463", "reason_for_recall": "Unapproved design changes to the products outside of the 510(k) clearance.", "root_cause_description": "Component change control", "action": "On February 27, 2026, the firm began notifying customers via email and first-class mail.\n\nCustomers were instructed to request over-labels to place on affected kits containing recalled syringes instructing them to remove the recalled component and replace with product from their supply.", "product_quantity": "270,311 total", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.", "openfda": { "registration_number": [ "3015225571", "3014925393", "2030624", "3007329020", "1054241", "3008513424", "1643817", "3009605245", "3045816907", "1043214", "1423537", "1061124", "3006950086", "3009888344", "3004605321", "3012536737", "3004122598", "3011642792", "3005012805", "3033589330", "3007289408", "1319639", "2320762", "3004111573", "1055236", "3002807314", "3004519921", "1030451", "3035642068", "1018470", "3012964172", "1625425", "1422634", "1721676", "9616088", "3015173212", "1125782", "3007138831", "3015309643", "2029015", "3004911384", "3015910259", "1928237", "3005595283", "3045816902", "1047429", "3002834291", "1423395", "1123137", "1724474", "9616662", "1721504" ], "fei_number": [ "3015225571", "3014925393", "3000206435", "3007329020", "3008513424", "3003040625", "1643817", "3009605245", "3045816907", "1043214", "1000112968", "3006950086", "3009888344", "3004605321", "3012536737", "3004122598", "3011642792", "3005012805", "1000112877", "3002975287", "3033589330", "3007289408", "3000717925", "1000514656", "3004111573", "3000335778", "1000123180", "3002807314", "3035642068", "1018470", "1000138054", "3012964172", "1625425", "3003094851", "1000160458", "1721676", "3005846326", "3015173212", "3007138831", "3015309643", "3004911384", "3015910259", "3001236905", "1928237", "3005595283", "3045816902", "1047429", "3002834291", "1000512168", "1030451", "1721504", "3002902735" ], "device_name": "Angiography/Angioplasty Kit", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1650", "device_class": "2" } } ] }