{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "217421", "product_res_number": "Z-0956-2026", "event_date_initiated": "2025-10-09", "event_date_posted": "2025-12-18", "recall_status": "Open, Classified", "res_event_number": "97890", "product_code": "LRK", "product_description": "Myosa for Kids\nKS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc\n\nKS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc\n\nMyosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to\naddress breathing and myofunctional disorders.\nCatalog Numbers:", "code_info": "Myosa for Kids\nKS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc\n-S1 Large Blue\n-S1 Large Clear\n-S1 Medium Blue\n-S1 Medium Pink\n-S1 Small Blue\n-S1 Small Pink\n\nKS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc\n-Stage 2 Large Blue\n-Stage 2 Large Clear\n-Stage 2 Medium Blue\n-Stage 2 Medium Clear\n-Stage 2 Medium Pink\n-Stage 2 Small Blue\n-Stage 2 Small Clear", "firm_fei_number": "3005505603", "recalling_firm": "Myofunctional Research Company USA", "address_1": "9627 Charles Smith Avenue", "city": "Rancho Cucamonga", "state": "CA", "postal_code": "91730", "additional_info_contact": "Keah Jenkins\n909-587-4940", "reason_for_recall": "Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.", "root_cause_description": "No Marketing Application", "action": "On 10/09/2025, the firm emailed an \"URGENT: Medical Device Recall\" letter to customers informing them that products (Myosa for Kids KS1 and Myosa for Kids KS2) were distributed in the United States without the required FDA premarket clearance.\n\nCustomers are instructed to:\n1. Immediately examine their inventory for the affected products.\n2. Cease distribution/use of any remaining Myosa KS1 and KS2 devices.\n3. Quarantine affected stock to prevent further use.\n4. Complete and return the enclosed Response Form within 10 business days, even if customers no longer have any affected product.\n5. Return quarantine devices using the instructions provided after receipt of customer response forms\n\nFor any patient who has initiated treatment with the affected devices or to whom you have not explained the risks associated with these devices, it is requested that you notify them and provide warning s and clinical alternatives as appropriate.\n\nFor questions and/or assistance - Contact Recall Coordinator at 909-587-4940 or email usa.hq@myoresearch.com", "product_quantity": "436 devices", "distribution_pattern": "U.S. (nationwide) distribution to states of: Nationwide: AK, AR, CA, CO, FL, GA, HI, IL, KS, KY, LA, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OR, PA, TX, UT, VA, and WA; O.U.S. (foreign) to country of: Australia", "openfda": { "k_number": [ "K253355", "K111110", "K182202", "K991948", "K033822", "K090503", "K250482", "K143591", "K163580", "K073004", "K140777", "K253868", "K022284", "K102463", "K152292", "K130504", "K113022", "K132933", "K972061", "K182661", "K993381", "K991209", 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"K183443", "K252698", "K093340", "K042161", "K170692", "K120371", "K252161", "K234089", "K132506", "K131138", "K133683" ], "registration_number": [ "3005730680", "3017520337", "3010347083", "3025124", "3030914478", "1825660", "3027346720", "3010324114", "3010022489", "3017092365", "3004964738", "3013652641", "3009495876", "3003283852", "3008583502", "3008274496", "3009549313", "1045254", "2031093", "3010767848", "3031282374", "3028271666", "3008313791", "3013445151", "3011649314", "1048735", "3007616887", "3008159012", "3005343849", "3039643908", "3015989643", "3030562551", "1420088", "3018783197", "3012728846", "3006038700", "3005598536", "3009401301", "3021282544", "3015169722", "3012539501", "3004860162", "3002911411", "3008186372", "3003460151", "3000171384", "3015128224", "3008763803", "3005726841", "3010852338", "3022315836", "3018783526", "3003928050", "2082148", "3006098230", "3012716038", "3013934196", "3002916277", "8010019", "2518422", "3017927175", "3008797926", 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