{ "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": 31 } }, "results": [ { "cfres_id": "219366", "product_res_number": "Z-2008-2026", "event_date_initiated": "2026-03-19", "event_date_posted": "2026-04-30", "recall_status": "Open, Classified", "res_event_number": "98664", "product_code": "HBA", "k_numbers": [ "K140369" ], "product_description": "Medline Neuro Sponges, various dimensions, labeled as: \n1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25\" X 0.25\", XR, 10/PK, Medline SKU NEUROSPNG02; \n2. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5\" X 0.5\", XR, 10/PK, Medline SKU NEUROSPNG05; \n3. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5\" X 1\", XR, LF, 10/PK, Medline SKU NEUROSPNG06; \n4. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5\" X 1.5\", XR, LF, 10/PK, Medline SKU NEUROSPNG07; \n5. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5\" X 3\", XR, LF, 10/PK, Medline SKU NEUROSPNG09; \n6. Neuro Sponges, Eponges neuro, Neuroesponjas, size .75\" X .75\", XR, LF, 10/PK, Medline SKU NEUROSPNG11; \n7. Neuro Sponges, Eponges neuro, Neuroesponjas, size 1\" X 1\", XR, LF, 10/PK, Medline SKU NEUROSPNG13; \n8. Neuro Sponges, Eponges neuro, Neuroesponjas, size 1\" X 3\", XR, LF, 10/PK, Medline SKU NEUROSPNG14.", "code_info": "1. NEUROSPNG02: UDI/DI each 10197344111572, UDI/DI case 20197344111579, ALL LOTS; \n2. NEUROSPNG05: UDI/DI each 20080196286659, UDI/DI case 30080196286656, ALL LOTS; \n3. NEUROSPNG06: UDI/DI each 20080196286505, UDI/DI case 30080196286502, ALL LOTS; \n4. NEUROSPNG07: UDI/DI each 10080196286485, UDI/DI case 40080196286486, ALL LOTS; \n5. NEUROSPNG09: UDI/DI each 20080196286536, UDI/DI case 30080196286533, ALL LOTS; \n6. NEUROSPNG11: UDI/DI each 20080196286550, UDI/DI case 30080196286557, ALL LOTS; \n7. NEUROSPNG13: UDI/DI each 10080196286577, UDI/DI case 40080196286578, ALL LOTS; \n8. NEUROSPNG14: UDI/DI each 10080196286584, UDI/DI case 40080196286585, ALL LOTS.", "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": "During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.", "root_cause_description": "Under Investigation by firm", "action": "Medline industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 3/19/2026 via USPS first class mail and email. The notice explained the issue, potential health risk, and requested the following actions be taken on the affected sponges: Identify and quarantine affected product, complete response form using website link: https://recalls.medline.com, destroy affected product. Credit will be issued once response form is received. If the product has been further distributed, sold, or transferred, notify the customer to destroy the product. Distributors must notify their customers and should include customer quantities on your response form. For consignees of Medline medical convenience kits containing the affected sponges the actions to be taken are as follows: Identify and quarantine all affected kits, complete response form using website link: https://recalls.medline.com. 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 prior to using the kit. These labels will be provided via FedEx overnight, if applicable. Distributors must notify their customers and should include customer 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.\nIf you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.", "product_quantity": "4225160 units", "distribution_pattern": "Worldwide distribution.", "openfda": { "k_number": [ "K993019", "K891993", "K014268", "K193346", "K923027", "K854713", "K073576", "K862494", "K844594", "K970328", "K914600", "K880402", "K031008", "K020736", "K973083", "K902921", "K062406", "K121822", "K112598", "K962807", "K140369", "K904514", "K770894", "K950647" ], "registration_number": [ "1054241", "1047843", "3013557562", "9611024", "3013298431", "1043214", "9612501", "1060680", "3014334038", "1048735", "3003418325", "3012494290", "1219071", "3011862887", "3011089435", "1417592", "2244478", "3018094310", "3004950768", "3038718579", "2320762", "1219313", "3005663073", "1055236", "3030733800", "3027977504", "3012421607", "1220477", "1045254", "1055789", "1319660", "9680271", "1221144" ], "fei_number": [ "3003040625", "1047843", "3013557562", "1000159144", "3013298431", "1000136478", "1043214", "1000112968", "1000208624", "3014334038", "3003495548", "1000112877", "1048735", "3003418325", "3012494290", "3011862887", "3011089435", "1417592", "3018094310", "3004950768", "3038718579", "1219313", "3005663073", "3030733800", "3027977504", "1000110991", "1000136269", "3002807170", "3012421607", "1220477", "1045254", "3003259710", "1221144" ], "device_name": "Neurosurgical Paddie", "medical_specialty_description": "Neurology", "regulation_number": "882.4700", "device_class": "2" } } ] }