{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "221662", "product_res_number": "Z-2994-2026", "event_date_initiated": "2026-07-08", "event_date_posted": "2026-08-21", "recall_status": "Open, Classified", "res_event_number": "99489", "product_code": "OGR", "product_description": "Medline medical convenience kits, labeled as: \n1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; \n2) ENT PACK, Medline Kit SKU DYNJ40154D; \n3) ENT PACK, Medline Kit SKU DYNJ40154F; \n4) ENT SCOPE PACK, Medline Kit SKU DYNJ44480D; \n5) ENT NASAL ORAL PACK MOSES, Medline Kit SKU DYNJ58928A; \n6) HEAD & NECK PACK, Medline Kit SKU DYNJ83296; \n7) TRANSPHENOIDAL PACK, Medline Kit SKU DYNJ89006; \n8) SINUS, Medline Kit SKU DYNJ900537D; \n9) SINUS, Medline Kit SKU DYNJ900537F; \n10) ENT HEAD & NECK, Medline Kit SKU DYNJ903679F; \n11) ENT HEAD & NECK, Medline Kit SKU DYNJ903679G; \n12) ENT HEAD & NECK, Medline Kit SKU DYNJ903679I; \n13) ENT HEAD & NECK, Medline Kit SKU DYNJ903679J; \n14) ENT HEAD & NECK, Medline Kit SKU DYNJ903679K.", "code_info": "Medline Kit SKU DYNJ0966146F, UDI/DI 10193489916379 (each) 40193489916370 (case), Lot Number 23HBC070; \nMedline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 24CBA416; \nMedline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23CBS214; \nMedline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23FBC803; \nMedline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23GBU042; \nMedline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23IBO417; \nMedline Kit SKU DYNJ40154F, UDI/DI 10195327679293 (each) 40195327679294 (case), Lot Number 24EBH594; \nMedline Kit SKU DYNJ40154F, UDI/DI 10195327679293 (each) 40195327679294 (case), Lot Number 24FBQ494; \nMedline Kit SKU DYNJ40154F, UDI/DI 10195327679293 (each) 40195327679294 (case), Lot Number 24JBK316; \nMedline Kit SKU DYNJ44480D, UDI/DI 10198459241727 (each) 40198459241728 (case), Lot Number 25CDA135; \nMedline Kit SKU DYNJ58928A, UDI/DI 10193489763973 (each) 40193489763974 (case), Lot Number 23HBK833; \nMedline Kit SKU DYNJ83296, UDI/DI 10195327258917 (each) 40195327258918 (case), Lot Number 24FBQ476; \nMedline Kit SKU DYNJ83296, UDI/DI 10195327258917 (each) 40195327258918 (case), Lot Number 23EBI941; \nMedline Kit SKU DYNJ83296, UDI/DI 10195327258917 (each) 40195327258918 (case), Lot Number 23HBX888; \nMedline Kit SKU DYNJ83296, UDI/DI 10195327258917 (each) 40195327258918 (case), Lot Number 22KBR883; \nMedline Kit SKU DYNJ89006, UDI/DI 10198459241970 (each) 40198459241971 (case), Lot Number 25JMC017; \nMedline Kit SKU DYNJ89006, UDI/DI 10198459241970 (each) 40198459241971 (case), Lot Number 25KMB183; \nMedline Kit SKU DYNJ89006, UDI/DI 10198459241970 (each) 40198459241971 (case), Lot Number 25AMG343; \nMedline Kit SKU DYNJ89006, UDI/DI 10198459241970 (each) 40198459241971 (case), Lot Number 25DMJ252; \nMedline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 23ABM594; \nMedline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 23DBQ757; \nMedline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 23EBL559; \nMedline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 22FBC585; \nMedline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 22GBO880; \nMedline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 22HBN179; \nMedline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 22HBU967; \nMedline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 25CME312; \nMedline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 25FME826; \nMedline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 24IMA157; \nMedline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 24IMF249; \nMedline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 23EBI617; \nMedline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 23GBJ097; \nMedline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 23HBS862; \nMedline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 23JBU735; \nMedline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 23KBI060; \nMedline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 23ABS340; \nMedline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 23ABS768; \nMedline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 23BBB045; \nMedline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 23HBP969; \nMedline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 22HBR343; \nMedline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 22HBT245; \nMedline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 22LBL269; \nMedline Kit SKU DYNJ903679G, UDI/DI 10195327488093 (each) 40195327488094 (case), Lot Number 24DBD707; \nMedline Kit SKU DYNJ903679G, UDI/DI 10195327488093 (each) 40195327488094 (case), Lot Number 24DBD912; \nMedline Kit SKU DYNJ903679G, UDI/DI 10195327488093 (each) 40195327488094 (case), Lot Number 24HBR037; \nMedline Kit SKU DYNJ903679G, UDI/DI 10195327488093 (each) 40195327488094 (case), Lot Number 24IBF556; \nMedline Kit SKU DYNJ903679G, UDI/DI 10195327488093 (each) 40195327488094 (case), Lot Number 24JBM973; \nMedline Kit SKU DYNJ903679G, UDI/DI 10195327488093 (each) 40195327488094 (case), Lot Number 23LBG405; \nMedline Kit SKU DYNJ903679I, UDI/DI 10198459225758 (each) 40198459225759 (case), Lot Number 25BBD293; \nMedline Kit SKU DYNJ903679I, UDI/DI 10198459225758 (each) 40198459225759 (case), Lot Number 25BBF473; \nMedline Kit SKU DYNJ903679I, UDI/DI 10198459225758 (each) 40198459225759 (case), Lot Number 25BBF871; \nMedline Kit SKU DYNJ903679J, UDI/DI 10198459313035 (each) 40198459313036 (case), Lot Number 25DBU804; \nMedline Kit SKU DYNJ903679J, UDI/DI 10198459313035 (each) 40198459313036 (case), Lot Number 25EBN687; \nMedline Kit SKU DYNJ903679J, UDI/DI 10198459313035 (each) 40198459313036 (case), Lot Number 25FBR466; \nMedline Kit SKU DYNJ903679K, UDI/DI 10198459399916 (each) 40198459399917 (case), Lot Number 25HBF447; \nMedline Kit SKU DYNJ903679K, UDI/DI 10198459399916 (each) 40198459399917 (case), Lot Number 25KBT345.", "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\n800-359-1704", "reason_for_recall": "Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.", "root_cause_description": "Nonconforming Material/Component", "action": "Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 7/8/2026 via USPS and email. The notice explained the issue, potential adverse health consequences, and requested the following: \n\"REQUIRED ACTION: \n1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. \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 form. \nWebsite link: https://recalls.medline.com \nRecall Reference #: R-26-112-FGX2 \nRecall Code: \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 and discard the affected component \nprior to using the kit. These labels will be provided via FedEx overnight, if applicable.\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. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product.\"\nFor questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.", "product_quantity": "2262 kits", "distribution_pattern": "US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.", "openfda": { "registration_number": [ "1643817", "3009203853", "3015173212", "3004911384", "1928237", "1054241", "1423395", "2320762", "3003418325", "1423537", "1923569", "3035642068", "3012811961", "1422634", "3004122598", "9616088", "1061124", "3026197444", "3004362278", "1047429", "3045816902", "3011137372", "3009888344", "1030451", "2029015", "3014925393", "1824619", "3018077422", "3004519921", "3005012805", "1043214", "1055236", "3010041511", "3007329020", "3005595283", "3001084743", "3004111573" ], "fei_number": [ "1643817", "3009203853", "3015173212", "3004911384", "1928237", "1000112968", "3000717925", "1000160458", "3005747797", "3003418325", "1923569", "3035642068", "3012811961", "3004122598", "3026197444", "3004362278", "1047429", "3045816902", "3009888344", "1000512168", "1030451", "3002902735", "3014925393", "1824619", "3003040625", "3018077422", "3005012805", "1043214", "3010041511", "1000112877", "3007329020", "3005595283", "3005846326", "3001084743", "1000514656", "3001236905", "3004111573" ], "device_name": "Ear, Nose, And Throat Surgical Tray", "medical_specialty_description": "Ear, Nose, Throat", "regulation_number": "874.4420", "device_class": "1" } } ] }