{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "211264", "product_res_number": "Z-0724-2025", "event_date_initiated": "2024-11-06", "event_date_posted": "2024-12-20", "recall_status": "Open, Classified", "res_event_number": "95806", "product_code": "OJG", "product_description": "Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; \n2) NEURO KIT, SKU CDS981327Q; \n3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; \n4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D; \n5) SCRIPPS SW NEURO PACK-LF, SKU DYNJ39836C; \n6) SCRIPPS SW NEURO PACK-LF, SKU DYNJ39836D; \n7) NEURO BUNDLE-LF, SKU DYNJ40095A; \n8) NEURO BUNDLE-LF, SKU DYNJ40095B; \n9) NEURO BUNDLE-LF, SKU DYNJ40095C; \n10) NEURO BUNDLE-LF, SKU DYNJ40095D; \n11) NEURO PACK-LF, SKU DYNJ42844D; \n12) WMC VP SHUNT PACK-LF, SKU DYNJ50629J; \n13) NEURO PACK, SKU DYNJ54255A; \n14) NEURO CHRISTUS, SKU DYNJ61190A; \n15) NEURO KIT, SKU DYNJ62854B; \n16) NEURO KIT, SKU DYNJ62854C; \n17) NEURO PACK NTX, SKU DYNJ66213D; \n18) NEURO PACK, SKU DYNJ67628C; \n19) BASIC NEURO CUSTOM, SKU DYNJ83387; \n20) BASIC NEURO CUSTOM, SKU DYNJ83387A; \n21) HALY NEURO PACK, SKU DYNJ87308; \n22) FHWC NEURO, SKU DYNJ906131B; \n23) CRANI, SKU DYNJ907865; \n24) KIT NEURO LAFAYETTE, SKU DYNJ908615C; \n25) GENERAL NEURO, SKU DYNJ909744", "code_info": "UDI-DI: CDS780119T, 10888277762688 (each), 40888277762689 (case), Lot Numbers: 20EBU829;\nUDI-DI: CDS981327Q, 10195327080365 (each), 40195327080366 (case), Lot Numbers: 22FMH830\n22FMF883;\nUDI-DI: DYNJ0311501I, 10889942265886 (each), 40889942265887 (case), Lot Numbers: 22DMF117;\nUDI-DI: DYNJ37741D, 10195327548940 (each), 40195327548941 (case), Lot Numbers: 24EMD032;\nUDI-DI: DYNJ39836C, 10193489510324 (each), 40193489510325 (case), Lot Numbers: 20JMB588\n20GMD367\n20EMB420\n20CMC383\n20CMA256;\nUDI-DI: DYNJ39836D, 10193489477177 (each), 40193489477178 (case), Lot Numbers: 22EMA431\n22CMC948\n22BMD597\n22AMG597\n21JMF846\n21IMA074\n21GMF465\n21GMC844\n21CME103\n21CMD623\n21BMC249;\nUDI-DI: DYNJ40095A, 10193489370690 (each), 40193489370691 (case), Lot Numbers: 21KME983\n21JMB244\n21JMB245\n21HMA330\n21EME688\n21DME512\n21CMA323\n20LMD710\n20HMB030;\nUDI-DI: DYNJ40095B, 10195327068325 (each), 40195327068326 (case), Lot Numbers: 22GMB406\n22EMA845\n22CME763;\nUDI-DI: DYNJ40095C, 10195327211028 (each), 40195327211029 (case), Lot Numbers: 22JMH236;\nUDI-DI: DYNJ40095D, 10195327281250 (each), 40195327281251 (case), Lot Numbers: 24HMC151\n24GMA340\n24DMK362\n24CMH592\n24BMF793\n24AMF590\n24AMD886\n23LMB475\n23KMD199\n23IMF930\n23HMG523\n23HMB850\n23GMI744\n23GMH136\n23FMD605\n23EMC157\n23CME914\n23BMC902\n22LME175;\nUDI-DI: DYNJ42844D, 10193489880564 (each), 40193489880565 (case), Lot Numbers: 22HBZ336;\nUDI-DI: DYNJ50629J, 10195327081324 (each), 40195327081325 (case), Lot Numbers: 22FBF021;\nUDI-DI: DYNJ54255A, 10889942765256 (each), 40889942765257 (case), Lot Numbers: 20LBO578\n20HBM398\n20FBW118\n20EBG032\n20DBF296;\nUDI-DI: DYNJ61190A, 10193489453355 (each), 40193489453356 (case), Lot Numbers: 23HBX568\n23GBU378\n23EBU255\n23EBB228\n23CBK006\n23BBF587\n22LBP590\n22LBO797\n22KBH699\n22JBI769\n22IBF404\n22HMF895\n22EMH841\n22DMI740\n22CMH488\n22CME013\n21JME676\n21IMG224\n21IMB620\n21GMC966\n21EMB917\n21BMD698\n21BMD492\n21BMB573;\nUDI-DI: DYNJ62854B, 10193489324402 (each), 40193489324403 (case), Lot Numbers: 20HBA904;\nUDI-DI: DYNJ62854C, 10193489426984 (each), 40193489426985 (case), Lot Numbers: 24ABR077\n23LBT405\n23KBM929\n23GBJ934\n23FBA134\n23DBP199\n23BBI534\n22LBQ392\n22IBU624\n22DBO531\n22DBE837\n21LBF713\n21LBF714\n21KBW798\n21KBU432\n21IBO584\n21EBS026\n21EBS045\n21ABD769\n21ABF202\n20JBF504;\nUDI-DI: DYNJ66213D, 10195327345129 (each), 40195327345120 (case), Lot Numbers: 23IBN119\n23HBT681\n23GBA060\n23FBF235\n23DBR382\n23CBI721;\nUDI-DI: DYNJ67628C, 10195327690342 (each), 40195327690343 (case), Lot Numbers: 24HMA885;\nUDI-DI: DYNJ83387, 10195327262945 (each), 40195327262946 (case), Lot Numbers: 22LBP363;\nUDI-DI: DYNJ83387A, 10195327365684 (each), 40195327365685 (case), Lot Numbers: 23IBS038\n23GBF619\n23EBP127\n23DBI802;\nUDI-DI: DYNJ87308, 10198459025631 (each), 40198459025632 (case), Lot Numbers: 24GMB920;\nUDI-DI: DYNJ906131B, 10193489932386 (each), 40193489932387 (case), Lot Numbers: 22FBP752\n22EBI045\n22EBH247;\nUDI-DI: DYNJ907865, 10193489908725 (each), 40193489908726 (case), Lot Numbers: 22CMB545\n22BMA169\n21HMB808;\nUDI-DI: DYNJ908615C, 10198459082702 (each), 40198459082703 (case), Lot Numbers: 24HBS615;\nUDI-DI: DYNJ909744, 10195327465636 (each), 40195327465637 (case), Lot Numbers: 24ALA727\n23JLA320", "firm_fei_number": "1417592", "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Karin Johnson\n866-359-1704", "reason_for_recall": "Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods", "root_cause_description": "Nonconforming Material/Component", "action": "An IMMEDIATE ACTION REQUIRED MEDICAL DEVICE RECALL notification letter dated 11/7/24 was sent to customers.\n\nREQUIRED ACTION:\n1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately.\n2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form.\n3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.\nThe login for completing the response form is:\nWebsite link: https://recalls.medline.comRecall \nReference #: R-24-209-FGX1\nRecall Code: Recall Code\n\n4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication.\n\nIf you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.", "product_quantity": "12,889 kits", "distribution_pattern": "US Nationwide. Canada.", "openfda": { "registration_number": [ "3005595283", "3007456622", "2029015", "3014925393", "3015443199", "3010155661", "3007329020", "1643817", "3009888344", "2433012", "3003418325", "3016577622", "1030451", "9680425", "3004111573", "3004911384", "1047429", "1423537", "3014334038", "3011144486", "3009337401", "1928237", "1423395", "1067162", "9616088", "3035642068", "3009420598", "1220477", "3002807314", "1123137", "3010635845", "3005012805", "3015173212", "1061124", "3004122598", "1923569", "3045816902" ], "fei_number": [ "1000160458", "3000717925", "3005595283", "3007456622", "3002902735", "3014925393", "3015443199", "3010155661", "3007596547", "3003831320", "3001236905", "3007329020", "1643817", "3009888344", "2433012", "3003418325", "3016577622", "1030451", "3004111573", "3004911384", "1047429", "3014334038", "3011144486", "3009337401", "1928237", "3035642068", "3009420598", "1000512168", "1220477", "1000123180", "3002807314", "3010635845", "3005012805", "3015173212", "3004122598", "1923569", "3045816902" ], "device_name": "Neurological Tray", "medical_specialty_description": "Neurology", "regulation_number": "882.4525", "device_class": "1" } } ] }