{ "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": "202833", "product_res_number": "Z-0169-2024", "event_date_initiated": "2023-08-10", "event_date_posted": "2023-11-01", "recall_status": "Open, Classified", "res_event_number": "92895", "product_code": "CCW", "product_description": "McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only", "code_info": "UDI: 10884521824386/ Lot # 22102001", "firm_fei_number": "2936999", "recalling_firm": "Covidien", "address_1": "6135 Gunbarrel Ave", "city": "Boulder", "state": "CO", "postal_code": "80301-3214", "additional_info_contact": "Technical Support\n800-255-6774 Ext. 4", "reason_for_recall": "Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured.", "root_cause_description": "Under Investigation by firm", "action": "On August 10, 2023 Medtronic ( Parent company of Covidien) issued an Urgent via UPS. Medtronic ask consignees to take the following actions:\n\n1. Quarantine all unused product from the affected lots of McGRATH MAC 2 disposable laryngoscope blades. See attachment A for guidance on identifying potentially affected devices.\n\n2. Return all unused product from the affected lots in your inventory to Medtronic as described on the Customer Confirmation Form.\n\n3. Please complete and return the enclosed Customer Confirmation Form even if you do not have unused inventory.\n\n4. Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product from the specified lots has been transferred or distributed.\n\n5. Adverse reactions or quality problems experienced with this product should be reported to FDA and Medtronic:\n. Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or\n. Call FDA (800) FDA-1088\n. Call Medtronic Quality Assurance at 800-255-6774 option 1, then option 1", "product_quantity": "42,367", "distribution_pattern": "US: AK\tAL\tAR\tAZ\tCA\tCO\tCT\tDE\tFL\tGA\tIA\tIL\tIN\tKS\tLA\tMA\tMD\tMI\tMO\tMT\tNC\tND\tNH\tNJ\tNM\tNY\tOH\tOK\tOR\tPA\tSD\tTN\tTX\tUT\tVA\tWA\tWI\tWY\n\nOUS: Australia\tAustria\tAzerbaijan\tBahamas\tBelgium\tCroatia\tCzech Republic\tDenmark\tFinland\tFrance\tFrench Guiana\tGermany\tGuadeloupe\tHong Kong\tHungary\tIreland\tIsrael\tItaly\tKazakhstan\tKorea, Republic Of\tMalta\tMayotte\tNetherlands\tNew Zealand\tNorway\tPakistan\tPoland\tPortugal\tReunion\tRomania\tSpain\tSweden\tSwitzerland\tTurkmenistan\tUnited Arab Emirates", "openfda": { "k_number": [ "K191602", "K830047", "K954446", "K062523", "K945901", "K831981", "K944428", "K851705", "K951804", "K905273", "K883830", "K883819", "K953179", "K882433", "K861026", "K944686", "K922019", "K915161", "K926158", "K971377", "K954787", "K945301", "K801452", "K833133", "K832984", "K883296", "K984101", 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"medical_specialty_description": "Anesthesiology", "regulation_number": "868.5540", "device_class": "1" } } ] }