{ "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": 7 } }, "results": [ { "cfres_id": "222138", "product_res_number": "Z-3121-2026", "event_date_initiated": "2026-08-11", "event_date_posted": "2026-09-14", "recall_status": "Open, Classified", "res_event_number": "99669", "product_code": "CAI", "product_description": "Medline Convenience Kits:\r\n1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A", "code_info": "1) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24HBH109;\n2) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24HBM182;\n3) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24HBS365", "firm_fei_number": "1417592", "recalling_firm": "Medline Industries, LP", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Haley Barclay\n866-359-1704", "reason_for_recall": "The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.", "root_cause_description": "Nonconforming Material/Component", "action": "An URGENT MEDICAL DEVICE RECALL notification letter dated 8/11/26 was sent to customers. This communication serves as an update to the Medline notification sent on June 12, 2026. Please be advised that the actions required for certain item(s) and lot(s) identified in the original notification have changed based on additional recall details received from BD (Becton, Dickinson and Company). \n\nREQUIRED ACTION:\n1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please 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 response form.\nWebsite link: https://recalls.medline.com\nRecall Reference #: R-26-097-FGX3\nRecall Code: \n3.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. Please request that customers destroy any affected product. You should include your customers quantities on your response form.\n\nIf you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.", "product_quantity": "12 kits", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K932485", "K952018", "K911736", "K905450", "K924627", "K811858", "K932582", "K884072", "K942127", "K801191", "K942122", "K840431", "K840056", "K954480", "K953788", "K904538", "K912504", "K823714", "K932193", "K873359", "K934462", "K781908", "K932589", "K911880", "K844149", "K800498", "K932195", "K953787", "K901739", "K852312", "K820352", "K911263", "K933641", "K760149", "K932780", "K952020", "K813382", "K854573", "K833088", "K842492", "K880683", "K932781", "K881141", "K952016", "K925543", "K821087", "K811413", "K932575", "K851193", "K770549", "K944429", "K833478", "K952014", "K932576", "K915452", "K830470", "K862003", "K895357", "K822769", "K770286", "K852316", "K942125", "K945984", "K891479", "K853065", 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"device_class": "1" } } ] }