{ "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": "87916", "product_res_number": "Z-0798-2010", "event_date_initiated": "2010-01-11", "event_date_posted": "2010-02-22", "recall_status": "Terminated", "event_date_terminated": "2011-04-21", "res_event_number": "54233", "product_code": "ETN", "k_numbers": [ "K003745" ], "product_description": "2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL)\nFor use as a Surgical stimulator/locator for recurrent laryngeal nerve.", "code_info": "Lot numbers 113008, 054409, 096709", "firm_fei_number": "1930870", "recalling_firm": "Neurovision Medical Products Inc", "address_1": "275 Burnett Ave", "city": "Ventura", "state": "CA", "postal_code": "93003", "additional_info_contact": "805-212-8306", "reason_for_recall": "This recall has been initiated due to a conductive glue used to attach the lead wire to electrode, which has been found in a small number of electrodes, to cause a short circuit in one of the channels. This is due to migration of the adhesive from one pad to the other creating an electrical short. Use of one of these defective electrodes could lead to a failure to monitor. Our investigation has c", "root_cause_description": "Other", "action": "URGENT RECALL: Medical Device Letter dated 1/7/10.\nThe letter identified the affected product and provided a list of necessary actions for customers to take.\n\nThe customers should immediately examine their inventory and quarantine product subject to recall. In addition, if they have further distributed this product, please identify their customers and notify them at once of this product recall. Their notification to their customers may be enhanced by including a copy of this recall notification letter.\n\nThis recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent any failure to monitor.\n\nPlease complete and return the enclosed response form as soon as possible. If you have any questions, call Ryan Rea or Kevin Rea, at 866-815-6999.", "product_quantity": "4143", "distribution_pattern": "Nationwide: CA CO FL GA IL LA MI ND NY OH PA TX UT WA WI)", "openfda": { "k_number": [ "K870272", "K051718", "K071349", "K091874", "K040543", "K933491", "K945242", "K020955", "K021595", "K133348", "K923056", "K982595", "K121931", "K925640", "K880720", "K873964", "K831715", "K232888", "K032083", "K912508", "K110712", "K934426", "K110696", "K014165", "K062549", "K843226", "K881757", "K072736", "K112686", "K031510", "K092729", "K003745", "K110138", "K152505", "K253536", "K063560", "K103128", "K991583", "K061365", "K110422", "K100992", "K934733", "K971143", "K895676", "K954601", "K212355", "K111597", "K110989", "K992869", "K874018", "K872791", "K895838", "K102862", "K925008", "K092292", "K093373", "K050162", "K150005", "K833646", "K063305", "K251672", "K781569", "K152769", "K951641", "K112435", "K112718", "K200886", "K031003", "K213246", "K122040", "K112717", 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