{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 7 } }, "results": [ { "cfres_id": "221741", "product_res_number": "Z-3005-2026", "event_date_initiated": "2026-07-09", "event_date_posted": "2026-08-21", "recall_status": "Open, Classified", "res_event_number": "99527", "product_code": "LRO", "product_description": "Brand Name: Halyard\nProduct Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK\nModel/Catalog Number: SAMM064-27", "code_info": "Lot Code: Lot Number: 1634391\nUDI: 10809160439708", "firm_fei_number": "1047429", "recalling_firm": "AVID Medical, Inc.", "address_1": "9000 Westmont Dr", "city": "Toano", "state": "VA", "postal_code": "23168-9351", "additional_info_contact": "Marlene Jones\n+1-844-4259273", "reason_for_recall": "Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.", "root_cause_description": "Labeling Change Control", "action": "On July 9, 2026 Avid Medical ( subsidiary of Owen & Minor) issued a Urgent: Medical Device correction notification to affected consignees. Avid Medical ask consignees to take the following actions: \n\n1. Identify, segregate, and quarantine all impacted product identified. \n\n2. Add warning labels to affected AVID kits to ensure all users are aware of the actions to discard the impacted component prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. \n\n3. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have.\n\n4. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness.\n\n5. Complete the attached Recall Response Form and return by July 24, 2026.", "product_quantity": "45 kits", "distribution_pattern": "US Nationwide distribution in the states of MS, TX.", "openfda": { "k_number": [ "K931759", "K905459", "K871434", "K902888", "K926269", "K874760", "K871322", "K935741", "K931673", "K931824", "K931760", "K925467", "K923600", "K885090", "K932220", "K952539", "K905004", "K914174", "K213481", "K934029", "K950295", "K041080", "K920267", "K963721", "K894685", "K934428", "K842648", "K961683", "K931820", "K882684", "K901856", "K935483", "K871437", "K910365", "K935740", "K951478", "K935743", "K890726", "K961863", "K884093", "K872011", "K971062", "K933137", "K965201", "K892389", "K931758", "K914036", "K934028", "K880961", "K951149", "K890570", "K925016", "K932217", "K934030", "K895202", "K964011", "K971061", "K880942", "K922648", "K980137", "K873973", "K930700", "K932652", "K883250", "K890098", "K902887", "K964921", "K930270", "K023276", "K030721", "K925214", 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