{ "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": "115660", "product_res_number": "Z-0838-2013", "event_date_initiated": "2013-01-14", "event_date_posted": "2013-02-20", "recall_status": "Terminated", "event_date_terminated": "2015-08-06", "res_event_number": "64246", "product_code": "HIS", "k_numbers": [ "K120394" ], "product_description": "LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303.\n\nA sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).", "code_info": "Zero Regular 10-Ct: SKU# 0-70907-20510-5 Master Case: 30070907205106.", "firm_fei_number": "3009964047", "recalling_firm": "Ansell Healthcare Products LLC", "address_1": "111 Wood Ave S", "address_2": "Suite 210", "city": "Iselin", "state": "NJ", "postal_code": "08830-2700", "additional_info_contact": "Robert S. Mahler\n732-345-2174", "reason_for_recall": "Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and Drug Administration. However, we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage, and so we are asking to have all products returned.", "root_cause_description": "Device Design", "action": "Ansell HealthCare Product LLC sent an Recall letter dated January 14, 2013, via registered mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\n\n The recall notification informs customers about the problem with the affected product and provides instructions to the customers on how to handle affected product. Customers are asked to complete the Response Form and return via fax (1-800) 722-8155.\n\nIf you have further questions, please contact our Customer Service Department at 1-800-952-9916.", "product_quantity": "469,134 units", "distribution_pattern": ".Nationwide Distribution including the states of AL, AZ, CA, CO, DE, FL, GA, IA, IN, IL, KS, KY, LA, MI, MN, MO.MS, NC, NH, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WI and UT.", "openfda": { "k_number": [ "K021125", "K221906", "K984218", "K041432", "K042957", "K931077", "K132107", "K884399", "K993887", "K073016", "K912405", "K210208", "K952393", "K993781", "K874921", "K901191", "K884469", "K884402", "K895530", "K150857", "K893039", "K172414", "K904840", "K830691", "K193578", "K864473", "K020633", "K875068", "K040085", "K940046", "K982924", "K042470", "K884925", "K211152", "K243640", "K902804", "K963679", "K994312", "K153016", "K984488", "K910578", "K865106", "K964599", "K860680", "K972427", "K032909", "K012653", "K864482", "K854247", 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"3003999964", "3008808138", "3004785585", "3015729142", "3029779", "3003071219", "2531449", "9616578", "1000136042", "3006799339", "3003896222", "8030344", "3026885377", "9616559", "9613994", "3007671445", "2025773", "3007962592", "3024836857", "2084177", "1718873", "8040211", "3004819929", "3003902978", "3003491851", "9612266", "3003963141", "3008062466", "1122329", "9680394", "3012909279", "3002997683", "3042262517", "8043142", "9680135", "2025771", "3038641388", "3015436035", "3013395518", "2280705", "1043214", "3011015568", "3039878168", "2938651", "3006122980", "3013986076", "3003592318", "1055236", "9613932", "3006479639", "9610410", "3005858760", "3003823186", "3005191252", "3015271338", "3010220595", "2020372", "3008559248", "2412672", "3003370588", "3013770781", "1054241", "3010599708", "1222115", "3003169402", "9616515", "2320762", "2086832", "1010604", "3013408180" ], "fei_number": [ "3007307589", "3003759643", "3007829481", "3006140792", "3003999964", "3008808138", 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"medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.5300", "device_class": "2" } } ] }