{ "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": 2 } }, "results": [ { "cfres_id": "197607", "product_res_number": "Z-1019-2023", "event_date_initiated": "2022-12-22", "event_date_posted": "2023-01-26", "recall_status": "Open, Classified", "res_event_number": "91391", "product_code": "CAE", "product_description": "Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA\nSize REF Number\n0.0 50005\n0.5 50055\n1.0 50105\n1.5 50155\n2.0 50205\n3.0 50305\n4.0 50405", "code_info": "ALL LOTS\n\n\nSize REF UDI/DI\n0.0 50005 Each: 00814954020188 Box: 10814954020185 Case: 20814954020182\n0.5 50055 Each: 00814954020195 Box: 10814954020192 Case: 20814954020199\n1.0 50105 Each: 00814954020201 Box: 10814954021007 Case: 20814954020205\n1.5 50155 Each: 00814954020218 Box: 10814954021014 Case: 20814954020212\n2.0 50205 Each: 00814954020225 Box: 10814954021021 Case: 20814954020229\n3.0 50305 Each: 00814954020232 Box: 10814954021038 Case: 20814954020236\n4.0 50405 Each: 00814954020249 Box: 10814954021045 Case: 20814954020243", "firm_fei_number": "1314417", "recalling_firm": "SunMed Holdings, LLC", "address_1": "2710 Northridge Dr Nw Ste A 2710 Northridge Dr Nw", "address_2": "Ste A", "city": "Grand Rapids", "state": "MI", "postal_code": "49544-9112", "additional_info_contact": "Rob Yamashita\n616-259-8400", "reason_for_recall": "There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.", "root_cause_description": "Under Investigation by firm", "action": "On December 22, 2022, the firm notified affected customers through Urgent Medical Device Product Correction letters.\n\nCustomers were informed that there is a discrepancy in the orogastric (OG) tube size indicated in the labeling in the instructions for use (IFU) versus the printed text on the device. Customers were provided with the correct recommended maximum OG tube/catheter sizes for each impacted Air-Q3G and Air-Q SPG model.\n\nIf product has been further distributed, customers should forward the recall notice.\n\nIf customers have questions about this recall notification, please contact Rob Yamashita, VP of Regulatory Affairs, at 616-259-8400, toll free at 800-433-2729, or ryamashita@sun-med.com.", "product_quantity": "43,290 (Eaches)", "distribution_pattern": "US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.", "openfda": { "k_number": [ "K862199", "K854029", "K860780", "K861540", "K850248", "K812822", "K822727", "K955721", "K810069", "K936134", "K833328", "K841120", "K832435", "K842605", "K880241", "K810651", "K874412", "K933760", "K833482", "K861482", "K791799", "K760488", "K855137", "K770001", "K860949", "K780601", "K950613", "K891586", "K820512", "K844873", "K832512", "K904834", "K033189", "K810099", "K130304", "K830767", "K821308", "K831078", 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