{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "217604", "product_res_number": "Z-1036-2026", "event_date_initiated": "2025-12-12", "event_date_posted": "2026-01-08", "recall_status": "Open, Classified", "res_event_number": "98091", "product_code": "GWM", "k_numbers": [ "K153347" ], "product_description": "Codman Microsensor Basic Kit. Catalog Number: 626631US. \n\nUse of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.", "code_info": "Catalog Number: 626631US. UDI-DI: 10381780514473. Lot Numbers: 7288007, 7288040, 7294017, 7305988, 7305989, 7305990, 7305991, 7307683, 7325489, 7336088, 7336089, 7336090, 7305992, 7346223, 7391752, 7391751, 7406650, 7406651, 7406652, 7408825, 7408826, 7408827, 7456174, 7456175, 7456176, 7456179, 7478039, 7478040, 7480073, 7480072, 7482162, 7503704, 7507495, 7503608, 7510153, 7510155, 7510154, 7534856, 7535008, 7535009, 7411809.", "firm_fei_number": "3003418325", "recalling_firm": "Integra LifeSciences Corp. (NeuroSciences)", "address_1": "1100 Campus Rd", "city": "Princeton", "state": "NJ", "postal_code": "08540-6650", "additional_info_contact": "Mary O'Neill\n609-275-0500", "reason_for_recall": "Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.", "root_cause_description": "Process control", "action": "Integra LifeSciences Corporation notified consignees on about 12/12/2025 via FedEx overnight mailing. Consignees were instructed to identify impacted part numbers and lot numbers on hand, remove them immediately from service and quarantine them, complete and return the Acknowledgement Form, and maintain the notice for records. Consignees were also instructed to forward the notification to those who utilize the product for awareness of the recall. Once the Acknowledgement Form is received, and noted that affected product are on hand, Customer Service will contact consignees and provide a Return Material Authorization (RMA) number and directions to return the affected product.", "product_quantity": "1,301 units", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX UT, VA WA and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia (Plurinational State of), Brazil, Canada, Chile, China, Colombia, Cyprus, Czechia, France, Georgia, Germany, Greece, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Kenya, Korea (the Republic of), Lithuania, Nepal, New Zealand, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Taiwan (Province of China), Thailand, Turkey, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the).", "openfda": { "k_number": [ "K840999", "K772063", "K981846", "K060554", "K133754", "K200630", "K201989", "K802100", "K121159", "K013930", "K071505", "K022553", "K051599", "K252241", "K183406", "K173192", "K880154", "K992591", "K062584", "K943987", "K112017", "K031086", "K050702", "K042728", "K854657", "K172209", "K053244", "K881183", "K232890", "K101133", "K113088", "K802137", "K121573", "K020285", "K013705", "K103206", "K813440", "K040235", "K790920", "K822636", "K840003", "K862012", "K201118", "K153347", "K120252", "K982702", "K071984", "K822864", "K020558", "K152670", "K210993", "K884823", "K141869", "K010422", "K072379", "K050720", "K161010", "K896834", "K883115", "K102875", "K980380", "K991222", "K844566", "K130529", "K032337", "K862820", "K802149", "K940648", "K853770", "K802138", "K102077", "K041838", "K890468", "K914479", "K022638", "K912139", "K931609", "K930221", "K974088", "K083378", "K131184", "K061640", "K182073", "K020780", "K882552", "K002392", "K945585", "K240821", "K162108", "K882286", "K883881", "K003759", "K983799", "K893395", "K853864", "K002765", "K863479", "K200456", "K801755", "K883518", "K250285", "K003905", "K962928", "K914735", "K171666" ], "registration_number": [ "3011689956", "3013944123", "3010611950", "3007029079", "3017180827", "3027605168", "3004920696", "2183744", "3007156625", "2953359", "3009171251", "2032112", "3028006458", "1721983", "3003730855", "1526863", "3023074935", "3002807315", "3003733874", "3012266672", "3018094310", "3023540124", "3007603826", "2029275", "3010948104", "3003418325", "3002808022", "3024673", "3008102042", "3043513133", "3005067367", "3013557562", "3008791915", "3013886523", "3010763671", "3001587388", "3008114965", "3003851947", "3014255018", "3015531529", "3015151147", "3042902796", "3006240422", "3017636737", "3004114361", "1836324", "2916714", "3023852420", "3006946348", "2023988", "9617601", "2030624", "9611274", "3002108226", "3004593495", "3006697299", "3006942548", "3009865268", "1220477", "3004070722", "9612501", "2024024", "9616567", "3012507533", "2011171", "3044156918", "8010468", "3014334038" ], "fei_number": [ "3011689956", "3013944123", "3010611950", "3007029079", "3017180827", "3004920696", "2183744", "3002808043", "3002998595", "3000206435", "1625382", "3028006458", "3003730855", "1526863", "3023074935", "3002807315", "3003733874", "3012266672", "3018094310", "3008133910", "3006759904", "3023540124", "3007603826", "3010948104", "3003418325", "3002808022", "3002534070", "3024673", "1000064530", "3043513133", "3013557562", "3001587388", "3008791915", "3013886523", "3010763671", "3008114965", "3003851947", "3014255018", "3015531529", "3015151147", "3042902796", "3017636737", "3002963732", "3004114361", "3002924544", "3003495548", "3023852420", "2916714", "3002806577", "3006946348", "2023988", "3002108226", "1000306431", "3004593495", "3546", "3003076831", "3006697299", "3006942548", "3000215205", "3009865268", "1220477", "3004070722", "2024024", "3012507533", "2011171", "3044156918", "3014334038" ], "device_name": "Device, Monitoring, Intracranial Pressure", "medical_specialty_description": "Neurology", "regulation_number": "882.1620", "device_class": "2" } } ] }