{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "199376", "product_res_number": "Z-1506-2023", "event_date_initiated": "2023-03-20", "event_date_posted": "2023-05-04", "recall_status": "Open, Classified", "res_event_number": "91987", "product_code": "KYT", "product_description": "DERMLITE DL4W, REF: DL4W, Rx Only MD, CE", "code_info": "Lot # 7654, serial numbers DL4WGXXXX & DL4WBXXXX (1304-1353 and 1504); UDI-DI: (01) 0 8559970", "firm_fei_number": "3003452144", "recalling_firm": "DermLite LLC", "address_1": "31521 Rancho Viejo Rd Ste 104 31521 Rancho Viejo Rd", "address_2": "Ste 104", "city": "San Juan Capistrano", "state": "CA", "postal_code": "92675-1868", "additional_info_contact": "Customer Service\n949-481-6384", "reason_for_recall": "Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.", "root_cause_description": "Error in labeling", "action": "On March 20, Dermlite LLC sent customers an email informing them of the issue. On March 29, 2023, Dermlite LLC, issued an \"Urgent Medical Device Recall\" via phone call. In addition to informing consignees about the recall, Dermlite asked consignees to take the following actions:\n\n1. Inspect your inventory and segregate the affected products from being used/sold. \n\n2. Dermlite will issue a corrected box label(s) and overnight it to your firm. \n\n3. For distributors: please trace where the remaining DL4W s were sold. If the products have left your facility to an end user, please notify the customer of this recall, provide corrected box label(s) to the customer and have them confirm when the boxes have been properly relabeled. \n\n4.Please confirm that you acknowledge receipt of this information and have understanding of the recall", "product_quantity": "32 units", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of CA, AZ, TX, FL, NE, IA, MO, CO and the countries of Saudi Arabia, Australia, Spain.", "openfda": { "k_number": [ "K841589", "K791001", "K841588", "K781228", "K920782", "K760972" ], "device_name": "Light, Examination, Medical, Battery Powered", "medical_specialty_description": "General Hospital", "regulation_number": "880.6350", "device_class": "1", "registration_number": [ "8020802", "3026312050", "3002562003", "3014414462", "3013466775", "3017573591", "1718873", "3015316279", "3012541976", "3018016862", "1651260", "1836161", "3011611571", "3017303999", 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