{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "105225", "product_res_number": "Z-0393-2012", "event_date_initiated": "2011-11-03", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2012-12-13", "res_event_number": "60386", "product_code": "HEB", "k_numbers": [ "K896994" ], "product_description": "Kotex Natural Balance Security tampons, regular absorbency, unscented. packaged in 18 count or 36 count retail containers. Consumer Services, Kimberly-Clark Corp. Dept. KNBTR-18, P.O. Box 2020, Neenah, WI 54957-2020 USA.\n\nTo absorb menstrual or other vaginal discharge.", "code_info": "Lot numbers (found in the red box located on bottom of package): 18-count: AC129321X, AC129421X, AC129521X, AC129621X, AC129721X, AC129821X, AC129921X  36 count: AC129325X, AC129425X, AC129525X, AC129625X, AC129725X, AC129825X, AC129925X", "firm_fei_number": "1000015879", "recalling_firm": "Kimberly-Clark Corporation", "address_1": "1400 Holcomb Bridge Rd", "city": "Roswell", "state": "GA", "postal_code": "30076", "additional_info_contact": "Consumer Services Division\n800-335-6839", "reason_for_recall": "A limited number of Kotex Natural Balance Security Unscented Tampons, regular absorbency, are being recalled after a raw material contaminated with a bacterium, Enterobacter sakazakii, was found when testing the plunger portion of the applicator.", "root_cause_description": "Material/Component Contamination", "action": "Kimberly-Clark sent an Urgent Product Recall letter, dated 11/09/2011, via FedEx to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify, quarantine, and discontinue use immediately. Customers were asked to complete the response form and fax to +1 (920) 380-6467. A Kimberly-Clark representative would contact them regarding return of the product, replenishement and/or account credit. \n\nFor questions regarding this recall call +1 (920) 216-8152.", "product_quantity": "1400 Cases (216 tampons per case)", "distribution_pattern": "Nationwide Distribution", "openfda": { "k_number": [ "K132595", "K780648", "K970954", "K962712", "K181911", "K872018", "K172118", "K001641", "K140077", "K861912", "K102445", "K941863", "K990536", "K020535", "K864648", "K152284", "K241064", "K142786", "K981760", "K182817", "K080733", "K870358", "K897007", "K924303", "K252613", "K211519", "K870361", "K861910", "K851355", "K090819", "K131543", "K222046", "K103311", "K811388", "K091084", "K852063", "K090071", "K960341", "K151170", "K130609", "K191431", "K963032", "K172504", "K861906", "K030474", "K952394", "K173225", "K232598", "K870359", "K864650", "K896112", "K896989", "K802193", "K844935", "K032636", "K811385", "K061486", "K861913", "K791274", "K161877", "K962476", 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"K162746", "K253719", "K961926", "K861907", "K062638", "K974629", "K190218", "K212272", "K965064", "K023479", "K923985", "K802760", "K842618", "K223749", "K864651", "K861911", "K864652", "K223883", "K110669", "K881384", "K182142", "K944154", "K211775", "K904937", "K800777", "K864750", "K864649", "K031067", "K920238", "K240708", "K811992", "K871642", "K944834", "K150897", "K944064", "K983478", "K833179" ], "registration_number": [ "3013235644", "3017195494", "1226146", "3006517653", "3006140792", "3013298431", "3011109575", "3017978050", "3019735068", "3013865802", "3009470597", "1000136042", "1648563", "3003896222", "3012736230", "3006241352", "3017125080", "3038182652", "3004402508", "3024836857", "3006015326", "3036679730", "3015522042", "3011050481", "3044091160", "3013445151", "3026610069", "3012934891", "3017654286", "3028725772", "3012097557", "3015375647", "3014128751", "3030979401", "3008925277", "3038282948", "3027520366", "8043647", "3010418793", "3045742347", "9615100", 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"3016010004", "3003701733", "1000184034", "3012118920", "3043534331" ], "device_name": "Tampon, Menstrual, Unscented", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.5470", "device_class": "2" } } ] }