{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210249", "product_res_number": "Z-0243-2025", "event_date_initiated": "2024-09-20", "event_date_posted": "2024-10-29", "recall_status": "Open, Classified", "res_event_number": "95432", "product_code": "HBA", "k_numbers": [ "K193346" ], "product_description": "SURG PAT XRAY 1/2X1-1/2\nModel/Catalog Number: 801404.\nThe surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.", "code_info": "UDI-DI: 10381780515005, 20886704036521\nNote: the same product code was distributed for a few years under JnJ under a transition agreement with Integra. Therefore, 2 UDI numbers are listed here for JnJ and for Integra.\nAll unexpired products.", "firm_fei_number": "3003418325", "recalling_firm": "Integra LifeSciences Corp.", "address_1": "1100 Campus Rd", "city": "Princeton", "state": "NJ", "postal_code": "08540-6650", "additional_info_contact": "Lacey Gigante\n1-609-2129004", "reason_for_recall": "Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods", "root_cause_description": "Nonconforming Material/Component", "action": "Integra issued 1st Notification- Urgent: Voluntary Medical Device Recall letter via E-mail and FedEx overnight mail on 9/20/24.\nLetter states reason for recall, health risk and action to take:\n1. If you do have units of the affected product listed in Table 1, remove them immediately from service and quarantine them.\n2. If you do have affected product, check the box on the enclosed Acknowledgement Form I do have affected product. Record the lot number and total quantity of the affected product that you have.\n3. Forward this notice to those who utilize the product so they are aware of this recall and can identify and quarantine any affected product that may remain in clinical areas.\n4. If you do not have affected product, check the box, I do not have affected product. \n5. Complete the rest of the Acknowledgement Form and return to FCA1@integralife.com or FAX to 1-609-750-4220.\n6. Keep a copy of the form for your records.\n7. When your form is received, and it is noted that you have affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the affected product. You can request a credit for the quantities which you returned.\nPLEASE NOTE THAT REGARDLESS OF WHETHER YOU HAVE THE AFFECTED PRODUCT TO RETURN OR NOT A COMPLETED ACKNOWLEDGEMENT IS REQUIRED\nAdditional actions to be Taken by Integra Sales Representatives and/or Distributors:\n7. Check your customer traceability records for shipments of above catalog and lot numbers.\n8. Forward a copy of the enclosed Field Safety Notice to any of your customers that have purchased the above catalog and lot number.\n9. Distributors can request a credit for the quantities which they returned.\n\nShould you have any questions regarding these instructions, please contact your Integra Sales Representative or Customer Service from Monday to Friday 8:00 a.m. 8:00 p.m. EST at 1-800-654-2873 or custsvcnj@integralife.com.", "product_quantity": "69179", "distribution_pattern": "Worldwide Distribution. US Nationwide, \nCanada\nGermany\nUnited Kingdom of Great Britain and Northern Ireland (the)\nMalta\nItaly\nBarbados\nTrinidad and Tobago\nAustralia\nNew Zealand\nNetherlands (the)\nBelgium\nFrance\nIreland\nSwitzerland\nBrunei Darussalam\nBahamas (the)\nSouth Africa\nChina\nEcuador\nKorea (the Republic of)\nCzechia\nKuwait\nLuxembourg\nFrench Guiana\nMayotte\nBurundi\nReunion\nMartinique\nPoland\nCosta Rica\nJapan\nSenegal\nTurkey\nSerbia\nMexico\nCambodia\nSpain\nGhana\nIceland\nJersey\nIraq\nBahrain\nLebanon\nDominican Republic (the)\nSingapore\nPortugal\nGreece\nAustria\nC¿te d'Ivoire\nPalestine, State of\nGeorgia\nNigeria\nSlovenia\nSweden\nColombia\nUnited Arab Emirates (the)\nSaudi Arabia\nQatar\nHong Kong\nOman\nAlbania\nPanama\nHoly See (the)\nKenya\nPakistan\nGuernsey\nMorocco\nChile\nBrazil\nArgentina\nPuerto Rico\nRwanda\nJordan\nPhilippines (the)\nHungary\nRomania\nBolivia (Plurinational State of)\nMalaysia\nEl Salvador\nPeru\nLithuania\nRepublic of North Macedonia\nTaiwan (Province of China)\nIsrael\nCyprus\nBulgaria", "openfda": { "k_number": [ "K020736", "K962807", "K844594", "K770894", "K193346", "K880402", "K121822", "K891993", "K140369", "K014268", "K073576", "K031008", "K914600", "K993019", "K973083", "K904514", "K902921", "K112598", "K062406", "K854713", "K950647", "K970328", "K862494", "K923027" ], "registration_number": [ "3012421607", "3030733800", "1219313", "3012494290", "1220477", "1221144", "3018094310", "2244478", "3011089435", "9612501", "1055236", "1319660", "1043214", "1060680", "1054241", "3005663073", "1048735", "1055789", "9611024", "3013298431", "3014334038", "3011862887", "2320762", "3038718579", "3013557562", "3004950768", "1047843", "1417592", "1219071", "1045254", "3003418325", "3027977504", "9680271" ], "fei_number": [ "3012421607", "3030733800", "1219313", "3012494290", "1220477", "1000110991", "3002807170", "1221144", "3003495548", "3018094310", "1000159144", "3011089435", "1000208624", "1043214", "1000112968", "3005663073", "1048735", "3013298431", "1000136478", "3003040625", "3014334038", "3011862887", "3038718579", "3013557562", "1000136269", "3004950768", "1047843", "1417592", "1000112877", "1045254", "3003418325", "3003259710", "3027977504" ], "device_name": "Neurosurgical Paddie", "medical_specialty_description": "Neurology", "regulation_number": "882.4700", "device_class": "2" } } ] }