{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "64562", "product_res_number": "Z-0182-2008", "event_date_initiated": "2007-07-03", "event_date_posted": "2007-11-16", "recall_status": "Terminated", "event_date_terminated": "2010-12-13", "res_event_number": "44944", "product_code": "FLG", "product_description": "Clarisonic Skin Care System - A hand held cleansing device for the skin. The Unit comes with a charger cradle for charging the device. Pacific Bioscience Laboratories, Inc., 13222 SE 30th St., Bellevue, WA 98005", "code_info": "All codes prior to 07177xx. (June 26, 2007). Lot codes are as follows: YYDDDxx, where DDD is the ordinal date. Handle codes are clearly printed on the bottom of the handle. All codes lot codes after, and including 07177xx are not subject to recall, and are followed by a \"T\" or \"J\" for ease in identification", "firm_fei_number": "3005492502", "recalling_firm": "Pacific Bioscience Lab, Inc.", "address_1": "13222 Se 30th St Ste A1 13222 Se 30th St", "address_2": "Ste A1", "city": "Bellevue", "state": "WA", "postal_code": "98005", "additional_info_contact": "David Giuliani\n425-283-1776", "reason_for_recall": "Overheating: The handle or charger/cradle can overheat, melting the plastic, which potentially can lead to smoke and fire and has caused mild user burns.", "root_cause_description": "Device Design", "action": "On August 30, 2007, the firm issued a press statement via PR Newswire and The Associated Press. They also posted a Recall Notice on their website (www.Clarisonic.com) requesting consumers to return their affected products for an exchange. All retailers and professional resellers were notified by telephone, E mail and/or letter and asked to return unsold inventory, as well as, post the provided point of sales notices and send provided post cards to known customers requesting exchange of recalled product. All users can contact the firm via the website or by phone at 1-866-378-7360 (6 am-6pm, M-F, Pacific Time) to arrange for the device exchange.", "product_quantity": "97,500", "distribution_pattern": "Worldwide Distribution - including USA and countries of Japan and Canada. Units were distributed to retailers and professional skin care clinics throughout the USA. In addition, units were distributed to one distributor in Japan and to 4 clinics in Canada.", "openfda": { "registration_number": [ "1825014", "2084725", "3015965671", "3030733800", "3038202587", "3001644167", "3005053820", "3013735167", "3017911818", "3013600135", "3010656982", "3022585053", "2424472", "3023339107", "3016447764", "2013558", "3011279497", "1815703", "2410887", "1000071265", "3002291107", "3008993611", "2248994", "1058458", "2244004", "3025307990", "3008812730", "8021896", "3013557562", "2216656", "3017268636", "1219113", "3006690139", "3010002722", "1932672", "2416455", "1937531", "2518897", "3024064703", "3010774780", "3030536467", "2031508", "3008887731", "3036269993", "3002564560", "3001061128", "2432177", "3018360321", "3032193293", "2437780", "8010273", "3009352510", "3021031939", "3043648115", "8022032", "2242327", "1000570445", "3035786158", "3042244574", "2529391", "3018811167", "3010446656", "3003120666", "3005544459", "3011774865", "3006316962", "3038718579", "3017177487", "3002718545", "2511556", "3014468707", "1836161", "3017618900", "3014683120", "3004506204", "3042989733", "3012421607", "9680101", "3003207991", "1720499", "3018047916", "3043126945", "9616031", "3011252807", "9612297", "3005558160", "1834190", "3015376465", "3035374295", "3004582535", "9617134", "3040277182", "1528319", "3005580113", "3011066654", "3030446844", "3040387587", "3031563141", "3012068831", "1926681", "1319130", "3009278339", "3011193403", "3012771684", "8022249", "2183301", "1410097", "3043626596", "2953749", "3008993610", "3010683450", "3034669683", "3000246414", "8030607", "9617172", "3023861999", "8043629", "3009968482", "3030430667", "3011632", "3021349683", "1941138", "3022516928", "3001547782", "3015276580", "3011191212", "3002821232", "3007527669", "3008559238", "3008648418", "3043709874", "3012138716", "3017221757", "2523320", "2515379", "3007697908", "3016458459", "2518690", "3042261334", "3007075140", "3016660845", "3011919098", "3008770252", "1933443", "3033280621", "1000355982", "3009185248", "3034731361", "3015547648", "3006723155", "3005695824", "3003639674" ], "fei_number": [ "1825014", "3015965671", "3030733800", "3038202587", "3001644167", "3005053820", "3013735167", "3017911818", "3008241044", "3010656982", "3013600135", "3022585053", "3003662624", "3023339107", "3016447764", "2013558", "1000080301", "3011279497", "1815703", "2410887", "1000071265", "3002291107", "3008993611", "2244004", "3025307990", "3008812730", "1000121497", "3013557562", "2216656", "3017268636", "1219113", "3006690139", "3010002722", "1000138339", "2416455", "1937531", "3024064703", "3010774780", "3030536467", "1000122656", "3008887731", "3001168737", "3036269993", "3001061128", "3002564560", "3018360321", "3032193293", "3009352510", "3021031939", "3043648115", "2242327", "1000570445", "3035786158", "3042244574", "3001746544", "3018811167", "3002806590", "3010446656", "3003120666", "1000160387", "3011774865", "3006316962", "3038718579", "3017177487", "3002718545", "3000166001", "2511556", "3014468707", "3002519584", "3017618900", "3000255542", "3014683120", "3004506204", "3042989733", "3012421607", "1000158594", "3003207991", "3002750084", "1720499", "3018047916", "3043126945", "1000510740", "1000273801", "3011252807", "1000555576", "3005558160", "3015376465", "3035374295", "3004582535", "3040277182", "3005580113", "3011066654", "3030446844", "3040387587", "3031563141", "3012068831", "1926681", "1319130", "3009278339", "3002809378", "3001717360", "3011193403", "3012771684", "2183301", "3002088145", "1410097", "3043626596", "3008993610", "3010683450", "3034669683", "3000246414", "3023861999", "3009968482", "3030430667", "3011632", "3021349683", "4486", "1941138", "3000718234", "3022516928", "3001547782", "3015276580", "3011191212", "3002821232", "3007527669", "3008559238", "3008648418", "3043709874", "3012138716", "3017221757", "2523320", "2515379", "3007697908", "3016458459", "2518690", "3042261334", "3007075140", "3001708019", "3016660845", "3011919098", "3008770252", "3000231474", "3033280621", "1000355982", "3009185248", "3012243493", "3034731361", "3015547648", "3006723155", "3006509795", "3005695824", "3003639674" ], "k_number": [ "K842754", "K944033", "K861590", "K862282", "K933149", "K940263", "K941163", "K934666", "K861592", "K771679", "K861147", "K931270", "K884660", "K935063", "K944950", "K861588", "K944494", "K861587", "K852527" ], "device_name": "Cleaner, Ultrasonic, Medical Instrument", "medical_specialty_description": "General Hospital", "regulation_number": "880.6150", "device_class": "1" } } ] }