{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "188884", "product_res_number": "Z-0178-2022", "event_date_initiated": "2021-08-09", "event_date_created": "2021-10-27", "recall_status": "Terminated", "event_date_terminated": "2023-10-13", "res_event_number": "88512", "product_code": "BTR", "k_numbers": [ "K792035" ], "product_description": "Bivona Uncuffed Wire Endotracheal Tubes,", "code_info": "SKU 15W080 Lots #'s: 3221795, 3221796, 3226185, 3250343, 3263023, 3272646, 3301497, \n3301498, 3312810, 3312811, 3315720, 3315721, 3338833, 3346070, 3361916, 3370107, 3379478, 3433337, 3437237, 3442378, 3442379, 3451013, 3459483, 3463690, 3491443, 3491444, 3491445, 3491446, 3491447, 3491448, 3507938, 3507939, 3507940, 3507941, 3512284, 3512285, 3517254, 3521999, 3531347, 3540954, 3545300, 3552748, 3565644,\n3569215, 3582745, 3608114, 3608131, 3615305, 3641651, 3680769, 3700904, 3707798,\n3782473, 3790044, 3890025, 3890026, 3890027, 3890028, 3890029, 3890030, 3890031,\n3890032, 3890033, 3907873, 3926897, 3985080 and 3991281.\nSKU 15W085\nSKU 15W090\nSKU 15W095", "firm_fei_number": "3012307300", "recalling_firm": "Smiths Medical ASD Inc.", "address_1": "6000 Nathan Ln N", "city": "Minneapolis", "state": "MN", "postal_code": "55442-1690", "additional_info_contact": "Mr. Dave Halverson\n763-383-3310", "reason_for_recall": "Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.", "root_cause_description": "Process control", "action": "Instructions to Consignees \n1. Locate and quarantine affected product in your possession.\n2. Determine the number of affected devices in your possession and\ncomplete the Response Form \n3. All affected product must be returned to Sedgwick for processing.\nA pre-paid return shipping label will be sent to you when the Response\nForm is returned indicating whether impacted devices are in your\npossession. \nInstructions to Distributors DISTRIBUTORS: \nif you have distributed potentially affected product to your customers, please immediately notify them of this Recall and instruct them to return the Response Forms to YOU for reconciliation. Please respond for each Distribution Center affected only", "product_quantity": "2191 devices", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, KY, MA, MN, MO, NE, NJ, NY, OH, PA, SD, TN, TX, VA, WA and Hawaii. 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