{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216459", "product_res_number": "Z-0504-2026", "event_date_initiated": "2025-10-14", "event_date_posted": "2025-11-14", "recall_status": "Open, Classified", "res_event_number": "97737", "product_code": "KYW", "product_description": "BD Luer Tip Caps;\nCatalog Number(s) or Model Number(s): 308341;", "code_info": "Catalog Number(s) or Model Number(s): 308341;\nUDI-DI: 50382903083416;\nLot Numbers: 5029670, 5034211, 5041975;", "firm_fei_number": "2243072", "recalling_firm": "Becton Dickinson & Company", "address_1": "1 Becton Dr", "city": "Franklin Lakes", "state": "NJ", "postal_code": "07417-1815", "additional_info_contact": "Darren Walsh\n201-847-6800", "reason_for_recall": "BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.", "root_cause_description": "Under Investigation by firm", "action": "On October 14, 2025, URGENT: MEDICAL DEVICE REMOVAL letters were sent to distributors and customers. Please Take the Following Actions:\n1. Cease use and destroy any unused affected product according to your facilities regulations. BD will provide credit for all product destroyed.\n2.\tIdentify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this field action notification on BD s behalf.\n3.\tComplete the attached Distributor Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification.\n4.\tReport any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: \nWeb: MedWatch website at www.fda.gov/medwatch\nPhone: 1-800-FDA-1088 (1-800-332-1088)\nMail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787\n5.\tReport any complaints experienced with the use of this product to BD via the North American Regional Complaint Center:\nPhone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted Mon Fri 8:00am and 5:00pm CT\nEmail: productcomplaints@bd.com", "product_quantity": "4180000 units", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Canada, Singapore, Hong Kong.", "openfda": { "k_number": [ "K800213", "K791345" ], "registration_number": [ "", "1043646", "3011700820", "3014334038", "3004941127", "1530671", "3008808082", 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