{ "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": 3 } }, "results": [ { "cfres_id": "195529", "product_res_number": "Z-1519-2022", "event_date_initiated": "2022-04-29", "event_date_posted": "2022-09-01", "recall_status": "Open, Classified", "res_event_number": "90711", "product_code": "ETN", "k_numbers": [ "K050162" ], "product_description": "NIM CONTACT EMG Endotracheal Tube, Part Numbers:\na) REF 8229508\nb) REF 8229507\nc) REF 8229506", "code_info": "a) REF 8229508; UDI 00643169789579, 00763000745868, 00763000882433; ALL LOTS.\n \nb) REF 8229507; UDI 00643169789562, 00763000745851, 00763000882426; ALL LOTS. \n\nc) REF 8229506; UDI 00643169789555, 00763000745844, 00763000882419; ALL LOTS.", "firm_fei_number": "1045254", "recalling_firm": "Medtronic Xomed, Inc.", "address_1": "6743 Southpoint Dr N", "city": "Jacksonville", "state": "FL", "postal_code": "32216-6218", "additional_info_contact": "Marie Gentile\n404-693-6028", "reason_for_recall": "The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.", "root_cause_description": "Under Investigation by firm", "action": "Medtronic sent an URGENT: MEDICAL DEVICE SAFETY NOTICE to impacted customers on 29-APR-2022 by mail. The letter explained the problem and provided Recommended Actions when using NIM Standard Reinforced EMG Endotracheal Tube & NIM CONTACT\" Reinforced EMG Endotracheal Tube and airway obstruction is encountered. Medtronic posted this issue to its US Product Performance and Advisories Information for Healthcare Professionals website on 3-May-2022. If you have any questions, contact your Medtronic ENT representative. Within the US, beginning 30-Jan-2024, Medtronic distributed a follow-up a notice via mail courier to all impacted consignees about availability of the updated IFU. \n\nOn about 07/08/2024, Medtronic distributed an additional notification to consignees to notify them to remove all lots of the NIM Contact\" EMG Reinforced Endotracheal Tubes and NIM\" (Standard) EMG Reinforced Endotracheal Tubes. Customers were instructed to not use the affected devices and to identify, segregate, quarantine, and return affected products to Medtronic using the Customer Confirmation Form. https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/products/ear-nose-throat/nim-contact-emg-reinforced-endotracheal-tubes.pdf.", "product_quantity": "81,555 units", "distribution_pattern": "Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Islamic Republic Of,\nIreland, Israel, Italy, Japan, Korea, Republic Of, Kosovo, Kuwait, Libya, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, North Macedonia, Northern Mariana Islands, Norway, Oman, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Slovakia, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and\nViet Nam", "openfda": { "k_number": [ "K213246", "K100992", "K894930", "K992869", "K880720", "K945242", "K112686", "K111671", "K112717", "K133348", "K121257", "K053141", "K103128", "K083242", "K031003", "K200886", "K253536", "K112709", "K021595", "K212355", "K905045", "K980148", "K062549", "K232888", "K102862", "K152505", "K873964", "K081742", "K945799", "K003745", "K093373", "K051718", "K122040", "K934426", "K010213", "K874018", "K230320", "K110422", "K982595", "K912508", "K843226", "K072736", "K954601", "K223254", "K110989", "K091874", "K933491", "K923056", "K063560", "K925008", "K970971", "K870272", "K111597", "K895676", "K092729", "K110696", "K112426", "K050162", "K991583", "K063305", "K040543", "K251672", "K242852", "K121931", "K031510", "K112718", "K230853", "K212164", "K092292", "K032083", "K071349", "K831715", "K241917", "K233001", "K014165", "K000507", "K231580", 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