{ "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": "169747", "product_res_number": "Z-0749-2019", "event_date_initiated": "2018-12-11", "event_date_created": "2019-01-17", "recall_status": "Terminated", "event_date_terminated": "2021-06-02", "res_event_number": "81759", "product_code": "HEB", "k_numbers": [ "K112635" ], "product_description": "U by Kotex Sleek, Regular Tampons, 34 Count", "code_info": "Package UPC: 36000426649; Case UPC: 10036000426646;   Lot Numbers: NN628101A, NN628101B, NN628201A, NN628201B, NN629401A, NN629401B, NN631201B, NN631301A, NN632113B, NN632213A, NN633813D, NN634113B, NN634213A, NN635113C, NN703113A, NN703113B, NN705613C, NN706313C, NN706313D, NN706413C, NN706413D, NN707713C, NN707713D, NN711313C, NN711313D, NN711413A, NN713013B, NN713113A, NN714313B, NN714413A, NN714413B, NN719313B, NN719413A, NN722013B, NN722113A, NN722113B, NN722213A, NN724713A, NN724713B, NN726713D, NN726813A, NN728213B, NN728313A, NN729613A, NN729613B, NN729713A, NN732513B, NN732613A, NN733913A, NN733913B, NN735213B, NN735313A, NN801413C, NN801413D, NN802813D, NN802913A, NN804213D, NN804313A, NN805813A, NN805813B, NN807513D, NN807613C, NN809913A, NN811213C, NN811213D, NN815413D, NN816813D, NN818113C, NN818113D, NN822413D, NN822513A, NN824613B, NN824713A, NN826713A.", "firm_fei_number": "3003701733", "recalling_firm": "Kimberly-Clark Corporation", "address_1": "2100 Winchester Rd", "address_2": "Po Box 349", "city": "Neenah", "state": "WI", "postal_code": "54956-9317", "additional_info_contact": "Terry Balluck\n920-721-2000", "reason_for_recall": "Potential for tampon to come apart upon removal.", "root_cause_description": "Under Investigation by firm", "action": "Kimberly-Clark issued a press release on 12/20/2018 and also notified customers via a \"MEDICAL DEVICE RECALL\" letter. The press release instructed consumers to stop using the product immediately and promptly contact Kimberly-Clark's Consumer Service team at 1-888-255-3499 between 7:30 a.m. 7:00 p.m. Central Time, Monday through Friday, for information regarding this recall. It also indicated that retailers have been alerted to remove the recalled lot numbers from shelves and post a notification in their stores. \n\nThe customer letter instructed customers to review their store and distribution center inventory to remove affected product from store shelves and inventory, and to post the recall letter in their store. Any affected product should be placed on hold and arrangements should be made with Stericycle at 877-567-9324 for pickup and removal of affected product. If affected product is returned from retail stores, those customers should also make arrangements to send that product to Stericycle. Customers were also provided with and asked to complete and return the provided \"Medical Device Recall Form.\"\n\nQuestions should be directed to Kimberly-Clark's Consumer Care Team (1-888-255-3499), between 7:30 a.m. 7:00 p.m. Central Time, Monday through Friday. Consumers who experience vaginal injury (pain, bleeding, or discomfort), vaginal irritation (itching or swelling), urogenital infections (bladder and/or vaginal bacterial and/or yeast infections), or other symptoms such as hot flashes, abdominal pain, nausea, or vomiting following use of the impacted product should seek immediate medical attention.", "product_quantity": "68,852,076 units total", "distribution_pattern": "Nationwide distribution AR, AZ, CA, CT, FL, HI, IA, ID, IL, KS, LA, MA, MD, MI, MN, MO, MS, NC, NH, NY, OH, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI.\n\nInternational distribution to Canada.", "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", "K252005", "K201003", "K951924", "K971228", "K133244", "K182814", "K212479", "K091281", "K122603", "K141294", "K242105", "K896994", "K212277", "K251033", "K090098", "K853192", "K963034", "K970232", "K992493", "K232060", "K864859", "K231341", "K832818", "K871715", "K180167", "K861908", "K112635", "K062001", "K953333", "K091749", "K893725", "K151470", "K813642", "K230419", "K820174", "K002096", "K983381", "K894846", "K080775", "K252939", "K944155", "K950194", "K883867", "K861909", "K220238", "K051290", "K812870", "K923932", "K930400", "K971174", "K954942", "K851356", "K113699", "K180850", "K912552", "K844936", "K885194", "K941936", "K991118", "K896113", "K120481", "K914430", "K912941", "K870360", "K942418", "K212304", "K870539", "K970108", "K092054", "K023789", "K790385", "K811983", "K040999", "K851941", "K980478", "K863464", "K993794", "K050660", "K842619", "K191666", "K981953", "K211469", "K192557", "K954445", "K780243", "K896114", "K930149", "K182813", "K113036", "K884305", "K897008", "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", "9710006", "3015259875", "3027995427", "3015391081", "3022076670", "3005836389", "3017025817", "3010692191", "3007838093", "3030234187", "3024787082", "3030534974", "3014193134", "3006073016", "3030019161", "3012117640", "3026199504", "3014829931", "3007740671", "1219109", "2938651", "9613295", "3013557562", "8043323", "1651897", "3010749695", "1523399", "3014833751", "2515444", "3004069780", "1000219986", "3030516298", "3012133441", "3013354376", "3006479639", "3003500682", "3010167805", "3043048216", "3015271338", "3017125176", "3042370478", "3003559457", "3008381943", "3004764532", "3026612204", "3004443383", "3021389492", "3043603999", "3022221320", "3011964664", "3016010004", "3003701733", "3012118920", "3043534331" ], "fei_number": [ "1000312280", "3013235644", "1000208912", "3017195494", "3006517653", "3009410230", "3006140792", "3013298431", "3011109575", "3017978050", "3019735068", "3013865802", "3009470597", "1000136042", "3000205942", "3012736230", "3006241352", "3017125080", "3010687142", "3038182652", "3004402508", "3024836857", "3006015326", "3036679730", "3015522042", "3002680121", "3011050481", "3044091160", "3026610069", "3012934891", "3017654286", "3028725772", "3012097557", "3015375647", "3004334060", "3030979401", "3038282948", "3027520366", "3010418793", "3045742347", "3006078362", "3001019699", "3027995427", "3015391081", "3022076670", "3005836389", "3017025817", "3010692191", "3007838093", "3030234187", "3024787082", "3012428604", "3030534974", "3014193134", "3006073016", "3030019161", "3012117640", "3026199504", "3014829931", "3007740671", "1219109", "2938651", "3013557562", "3010749695", "1523399", "3014833751", "2515444", "3004069780", "1000219986", "3030516298", "3012133441", "3013354376", "3006479639", "3003500682", "3010167805", "3043048216", "3015271338", "3017125176", "3042370478", "3003559457", "3008381943", "3004764532", "3026612204", "3011305786", "3004443383", "3021389492", "3043603999", "3022221320", "3011964664", "3016010004", "3003701733", "1000184034", "3012118920", "3043534331" ], "device_name": "Tampon, Menstrual, Unscented", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.5470", "device_class": "2" } } ] }