{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "211263", "product_res_number": "Z-0723-2025", "event_date_initiated": "2024-11-06", "event_date_posted": "2024-12-20", "recall_status": "Open, Classified", "res_event_number": "95806", "product_code": "LRO", "product_description": "Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVFF/FIBU #54-RF, SKU DYNJ21927S; 3) NEURO PEDIATRIC, SKU DYNJ61607A; 4) CRANIOTOMY PACK, SKU DYNJ66419C; 5) LYMPHATIC BYPASS PACK, SKU DYNJ69907; 6) LYMPHATIC BYPASS PACK, SKU \nDYNJ69907A; 7) HEAD AND NECK PACK - 51597, SKU DYNJ81934B; 8) MAJOR CRANIOTOMY PACK, SKU DYNJ82007A; 9) SPINE PACK, SKU DYNJ82011A; 10) CRANIOTOMY MERCY STK 256, SKU DYNJ84068; 11) WMC UNIVERSAL NEURO PACK, SKU DYNJ84496A; 12) SPINE PACK LF, SKU DYNJ85830; 13) AHT SPINE PACK, SKU DYNJ903566D; 14) LAMINECTOMY SPINAL FUSION PACK, SKU DYNJ909364A; 15) DIEP, SKU DYNJ909472; 16) AMBULATORY SINUS, SKU DYNJ910292; 17) AMBULATORY SINUS, SKU DYNJ910292A", "code_info": "UDI-DI: CDS982719X, 10198459064531 (each), 40198459064532 (case), Lot Numbers: 24IBE288;\nUDI-DI: DYNJ21927Q, 10889942885534 (each), 40889942885535 (case), Lot Numbers: 21LBB957\n21KBA966\n21IBN569\n21GBO771\n20KBB297\n20JBB045\n20IBI973\n20HBU423\n20HBC730\n20EBU633;\nUDI-DI: DYNJ21927S, 10195327576233 (each), 40195327576234 (case), Lot Numbers: 24GBQ357\n24GBK331\n24FBF951\n24CBV435\n24BBN342\n24ABW268;\nUDI-DI: DYNJ61607A, 10193489665734 (each), 40193489665735 (case), Lot Numbers: 22FLB055\n22FLA458;\nUDI-DI: DYNJ66419C, 10198459059353 (each), 40198459059354 (case), Lot Numbers: 24IBG439;\nUDI-DI: DYNJ69907, 10193489995558 (each), 40193489995559 (case), Lot Numbers: 22EMA026;\nUDI-DI: DYNJ69907A, 10195327163976 (each), 40195327163977 (case), Lot Numbers: 22FMB386;\nUDI-DI: DYNJ81934B, 10198459122910 (each), 40198459122911 (case), Lot Numbers: 24IBG522;\nUDI-DI: DYNJ82007A, 10195327635466 (each), 40195327635467 (case), Lot Numbers: 24IME319\n24HMI978\n24HMI081\n24CMA496;\nUDI-DI: DYNJ82011A, 10195327635480 (each), 40195327635481 (case), Lot Numbers: 24HMI979\n24GMJ808\n24GMB190\n24FMD601\n24EMD223\n24BMJ118;\nUDI-DI: DYNJ84068, 10195327332143 (each), 40195327332144 (case), Lot Numbers: 23HLA314;\nUDI-DI: DYNJ84496A, 10198459011245 (each), 40198459011246 (case), Lot Numbers: 24HBF172\n24FBN697;\nUDI-DI: DYNJ85830, 10195327556471 (each), 40195327556472 (case), Lot Numbers: 24IBG585\n24DBO636\n24BBK513;\nUDI-DI: DYNJ903566D, 10195327560829 (each), 40195327560820 (case), Lot Numbers: 24BBO346\n24BBK920\n24ABO451\n24ABO420;\nUDI-DI: DYNJ909364A, 10195327660420 (each), 40195327660421 (case), Lot Numbers: 24IMD666\n24IMB155\n24GMA069\n24EMH357;\nUDI-DI: DYNJ909472, 10195327368821 (each), 40195327368822 (case), Lot Numbers: 24IMD560\n24GMI069\n23LMG055\n23KMD713\n23GME971\n23GMA619;\nUDI-DI: DYNJ910292, 10195327618681 (each), 40195327618682 (case), Lot Numbers: 24HBI255\n24HBF816\n24GBR460\n24FBL017;\nUDI-DI: DYNJ910292A, 10198459111723 (each), 40198459111724 (case), Lot Numbers: 24IBK954", "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.", "distribution_pattern": "US Nationwide. Canada.", "openfda": { "k_number": [ "K854292", "K871459", "K871322", "K930700", "K945481", "K963443", "K951149", "K895202", "K926269", "K905459", "K925016", "K935743", "K914174", "K920292", "K931673", "K931844", "K932220", "K925216", "K963715", "K945160", "K932221", "K914037", "K936117", "K894685", "K872011", "K910368", "K935741", "K884093", "K944044", "K882684", "K935858", "K963721", "K934028", "K914935", "K902293", "K951478", "K922648", "K925214", "K931820", "K961863", "K872448", "K970187", "K902888", "K892389", "K023276", "K910365", "K931759", "K964921", "K931824", "K880942", "K890098", "K902887", "K945831", "K914036", "K932652", "K903336", "K980137", "K212258", "K970286", "K905004", "K924468", "K933137", "K890726", "K952539", "K925467", "K941846", "K934030", "K931760", "K874760", "K901856", "K935686", "K935483", "K871434", "K871873", "K971062", "K890729", "K934688", "K893814", "K934428", "K964011", "K880961", "K965201", "K962826", "K923600", "K873973", "K881083", "K213481", 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