{ "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": 1 } }, "results": [ { "cfres_id": "219695", "product_res_number": "Z-2173-2026", "event_date_initiated": "2026-04-10", "event_date_posted": "2026-05-13", "recall_status": "Open, Classified", "res_event_number": "98752", "product_code": "JXG", "k_numbers": [ "K170599" ], "product_description": "Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501.\n\nThe CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a series of drainage holes near the catheter's bullet shaped tip.", "code_info": "Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.", "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": "Sajeel Afzal\n1-640-2619909", "reason_for_recall": "Out-of-specification endotoxin result that did not meet the acceptance criteria.", "root_cause_description": "Process control", "action": "Integra notified consignees on about 04/10/2026 via letter. Consignees at medical facilities were instructed to examine inventory for affected units, remove them immediately from service and quarantine them, forward the notification to those who utilize the product so they are aware of the recall and can identify any affected product that may remain in clinical areas, and complete and return the \"Medical Facility Acknowledgement Form provided. Integra Customer Care will contact consignees who have noted affected product on hand and provide a Return Material Authorization (RMA) number and directions to return the affected product. \n\nDistributors were instructed to remove the product from further distribution, complete and return the Acknowledgement Form, check customer traceability records and notify them if they have any shipments of affected product, modify the acknowledgement form to provide to their customers, collect completed response forms and affected product from customers and report to Integra on distributor reply form. When the form is received, and it is noted that affected product is on hand, Integra Customer Care will contact distributors and provide a Return Material Authorization (RMA) number and directions to return the affected product.", "product_quantity": "40 packs (200 units)", "distribution_pattern": "US Nationwide distribution in the states of Arizona (AZ), Arkansas (AR), California (CA), Connecticut (CT), Florida (FL), Kentucky (KY), Louisiana (LA), Michigan (MI), Minnesota (MN), Missouri (MO), North Carolina (NC), North Dakota (ND), Oklahoma (OK), Oregon (OR), Texas (TX), Washington (WA).", "openfda": { "k_number": [ "K161992", "K913412", "K862513", "K905860", "K944595", "K150898", "K182265", "K904120", "K221918", "K914995", "K831396", "K855058", "K811288", "K033698", "K881616", "K981046", "K922936", "K042359", "K781768", "K870660", "K910853", "K760784", "K251598", "K021653", "K841442", "K820311", "K053107", "K980903", "K875205", "K061876", "K093968", "K110751", "K984053", "K823503", 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