{ "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": "196254", "product_res_number": "Z-0164-2023", "event_date_initiated": "2022-09-30", "event_date_posted": "2022-11-01", "recall_status": "Open, Classified", "res_event_number": "90946", "product_code": "LRO", "product_description": "MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.", "code_info": "GTIN (01) 40193489385404, Lot Number 22DBE139", "firm_fei_number": "1417592", "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Karin Johnson\n866-359-1704", "reason_for_recall": "Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.", "root_cause_description": "Under Investigation by firm", "action": "Medline disseminated MEDICAL DEVICE RECALL notice by US mail on 09/30/2022, The notices explained the issue and requested the following:\n\"REQUIRED ACTION:\n1.Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product.\n2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form.\nThe login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-22-149-FG Recall Code: RXXXXXXX\n3.Upon completion of the form, please destroy affected product. Your account will receive credit once the response form is submitted.\n4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers document and destroy any affected product. You should include your customers quantities on your response form.\nIf you have any questions, please contact the Recall Department at 866-359-1704.\"", "product_quantity": "60 units", "distribution_pattern": "US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.", "openfda": { "k_number": [ "K881083", "K903336", "K971062", "K941846", "K925467", "K931758", "K962826", "K932652", "K950295", "K874760", "K873973", "K902888", "K910365", "K924468", "K854095", "K964921", "K931820", "K902887", "K953083", "K871873", "K882684", "K951149", "K890729", "K030721", "K936117", "K041080", "K854292", "K945831", "K902293", "K970187", "K935483", "K944044", "K935743", "K890098", "K964011", "K922648", "K931824", "K910368", "K950574", "K871437", "K945160", "K905459", "K961863", "K920292", "K935740", "K914174", "K934428", "K871434", "K933137", "K971061", "K932220", "K926269", "K923600", "K913136", "K932221", "K914935", "K952539", "K935858", "K914037", "K884093", "K880961", "K922133", 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"regulation_number": "878.4370", "device_class": "2" } } ] }