{ "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": 10 } }, "results": [ { "cfres_id": "196584", "product_res_number": "Z-0233-2023", "event_date_initiated": "2022-10-14", "event_date_posted": "2022-11-14", "recall_status": "Open, Classified", "res_event_number": "91045", "product_code": "ELC", "k_numbers": [ "K190359" ], "product_description": "GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02", "code_info": "GentleWave System Anterior/Premolar Procedure Instrument (GW-APM-PI02)\nUDI-DI Code: 00858395006318\nLot Number: W2022080941R", "firm_fei_number": "3010817521", "recalling_firm": "Sonendo Inc", "address_1": "26051 Merit Cir Ste 104 26051 Merit Cir", "address_2": "Ste 104", "city": "Laguna Hills", "state": "CA", "postal_code": "92653-7008", "additional_info_contact": "Steven L. Ziemba\n949-667-8151", "reason_for_recall": "Procedure Instruments with erroneous unit carton labels.", "root_cause_description": "Under Investigation by firm", "action": "On 10/14/2022, the firm sent an \"URGENT PRODUCT ADVISORY NOTICE\" Letter via FedEx to customers informing them that there are error in the external labeling on the product carton. Information missing includes:\na) The GentleWave brand identification;\nb) The Sonendo brand identification;\nc) Information such as: \"Manufactured by:\" and various ISO informational labeling symbols\n\nCustomers are instructed:\n-Complete and return (fax or email) the Customer Acknowledgement Letter.\n-No other action are required. The product and the labeling on the product pouches inside the cartons is correct and unaffected by this error. The labeling has sufficient information to ensure that all customer can correctly identify different Procedure Instruments prior to use. This Notice is intended to reduce any possible confusion to the customer due to the labeling error.\n\nFor questions, contact Sonendo Customer Support between 7:00 a.m. to 4:00 p.m. (PST) at 1-844-468-5928 or via email to complaints@sonendo.com", "product_quantity": "15 instruments", "distribution_pattern": "Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.", "openfda": { "k_number": [ "K781044", "K791704", "K033764", "K171150", "K033044", "K021253", "K964320", "K904296", "K113530", "K812909", "K903163", "K863676", "K240707", "K832665", "K821810", "K791585", "K823134", "K982793", "K132445", "K760445", "K771557", "K953026", "K994203", "K921893", "K103498", "K881253", "K093723", "K201317", "K011179", "K153157", "K122501", "K050710", "K801689", "K071424", "K130862", "K012060", "K051547", "K950240", "K182145", "K930698", "K070866", "K002753", "K113717", "K242317", "K140990", "K053030", "K163414", "K082973", "K943403", "K140965", "K092417", "K853841", "K782133", "K051776", "K972026", "K132609", "K190124", "K852540", "K222096", "K130137", "K771556", "K031461", "K132322", "K170104", "K050895", "K942380", "K761246", "K053178", "K811023", "K160905", "K042972", "K110173", "K203302", "K023697", "K223173", "K970123", "K834283", "K072107", "K840141", "K900709", "K760805", "K052028", "K950256", "K923639", "K053578", "K014238", "K233922", "K990546", "K123139", "K132267", "K130693", "K260773", "K071981", "K122748", "K100401", "K991239", "K210832", "K230641", "K934714", "K032995", "K820162", "K002521", "K844250", "K983727", "K960889", "K791024", "K780808", "K223340", "K953919", "K951272", "K083059", "K081268", "K811396", "K130025", "K991874", "K852525", "K233844", "K071447", "K761247", "K002122", "K022328", "K031421", "K010195", "K842581", "K033705", "K880940", "K920328", "K052518", "K060171", "K190359", "K832664", "K080089", "K061448", "K213947", "K051910", "K081550", "K203615", "K052334", "K151023", "K130834", "K251689", "K832674", "K062731", "K000510", "K903298", "K033120", "K100647", "K811145", "K231391", "K864996", "K070307", "K000846", "K894247", "K093000", "K030111", "K991021", "K161639", "K901488", "K150535", "K983029", "K062791", "K140233", "K131997", "K132443", "K070975", "K992504", "K143448", "K042056", "K202906", "K942139", "K954820", "K902413", "K896749", "K033640", "K253254", "K033198", "K131151", "K053555", "K873146", "K060275", "K884221", "K040396", "K133752", "K191079", "K113430", "K941392", "K102218", "K933547", "K832443", "K970342", "K240801", "K050354", "K964596", "K994299", "K961158" ], "device_name": "Scaler, Ultrasonic", "medical_specialty_description": "Dental", "regulation_number": "872.4850", "device_class": "2", "registration_number": [ "3012494290", "9680864", "9614977", "3016075921", "2424472", "3011944170", "2243757", "3030126955", "2020943", "2024949", "2320721", "8043962", "9681479", "3005282635", "3008910197", "3038220293", "2433629", "3033858988", "3007962015", "3014315145", "3029780", 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