{ "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": "190299", "product_res_number": "Z-0332-2022", "event_date_initiated": "2021-11-12", "event_date_created": "2021-12-03", "recall_status": "Open, Classified", "res_event_number": "89024", "product_code": "LFL", "k_numbers": [ "K180149" ], "product_description": "Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status\nItem Code: CBCA", "code_info": "Serial Numbers: MCSB006939, MCSB006947\nGTIN: 10884521592896", "firm_fei_number": "1282497", "recalling_firm": "Covidien Llc", "address_1": "15 Hampshire St", "city": "Mansfield", "state": "MA", "postal_code": "02048-1113", "additional_info_contact": "SAME\n508-261-8000", "reason_for_recall": "Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit", "root_cause_description": "Under Investigation by firm", "action": "Medtronic customer communication translated by in-country representatives emailed on November 12, 2021. Letter states reason for recall, health risk and action to take:\n1. Please immediately quarantine and discontinue use of the affected item code with the associated serial numbers listed above.\n2. Please return affected product as indicated below. All products from the affected item code and associated serial numbers must be returned.\n3. If you have distributed the Covidien Sonicision\" Battery Chargers listed above, please promptly forward the information from this letter to those recipients.\n4. Complete the Recalled Product Return Form even if you do not have inventory.\n\nFax to 800-895-6140 or email to rs.covidienfeedbackcustomerservice@medtronic.com\nCredit for returned affected product will be issued based on the RGA number.\nException: Customers with zero inventory, fax to 651-367-2624 or email to rs.gmbfcamitg@medtronic.com", "product_quantity": "2 units OUS", "distribution_pattern": "Brazil", "openfda": { "k_number": [ "K933559", "K864983", "K010637", "K020220", "K964742", "K981262", "K050885", "K172691", "K070313", "K003824", "K101797", "K072904", "K990430", "K172595", "K994280", "K983065", "K950945", "K231117", "K161882", "K211273", "K221235", "K221835", "K071669", "K050776", "K111741", "K072203", "K240493", "K960374", "K962525", "K821820", "K212750", "K042777", "K150682", "K192963", "K223770", "K233036", "K060245", "K151136", "K123640", "K202299", "K113570", "K021989", "K851203", "K261448", "K962584", "K041566", "K212614", "K101561", "K051036", "K153299", "K213824", "K880814", "K210567", "K921251", "K243930", "K151101", "K980895", "K012753", "K000927", "K062544", "K151340", "K200427", "K053056", "K031305", "K042277", "K121550", "K181367", "K970471", "K934628", "K880166", "K931902", "K212049", "K153371", "K982841", "K993628", "K031523", "K883091", "K032066", "K852539", "K893926", "K190281", "K211838", "K971580", "K971302", "K221763", "K221790", "K031710", "K133314", "K190070", "K132522", "K933239", "K241700", "K980099", "K062000", "K980930", "K000095", "K042160", "K102258", "K063192", "K063531", "K032424", "K182809", "K971861", "K904010", "K012028", "K901974", "K910696", "K132512", "K190180", "K062471", "K021929", "K212060", "K880815", "K901737", "K081459", "K190160", "K212301", "K100597", "K180149", "K070360", "K141668", "K983199", "K010309", "K993054", "K971533", "K002906", "K942095", "K120729", "K972114", "K141371", "K983316", "K032690", "K160752", "K191555", "K801623", "K972148", "K150271", "K242894", "K010898", "K012176", "K960040", "K830753", "K251162", "K964601", "K971609", "K993868", "K932094", "K051947", "K141674", "K894600", "K200774", "K990572", "K221102", "K230427", "K021962", "K090864", "K132612", "K991791" ], "registration_number": [ "", "3030733800", "3015540957", "3011024991", "3015967359", "3012494290", "3003724334", "3018094310", "2030598", "3013188547", "3017196117", "9610612", "1724474", "3009941480", "3009380063", "2183715", "2032112", "3010684280", "3015895145", "3011063460", "3007487007", "3007997036", "1056128", "2029015", "3014932737", "3022626486", "3013557562", "3012627460", "3025663926", "3021194552", "3016555232", "2182291", "3006697299", "3009719225", "3016832577", "3014663814", "1928237", "9616696", "3014635169", "3013077751", "3004111573", "1056553", "3007713438", "3014461810", "3010408671", "2435119", "3002807314", "1650907", "1721676", "2011171", "1061124", "3021970868", "3016607092", "3041274936", "3008837339", "3010760216", "3015173212", "1219930", "3013247477", "3007829657", "2183967", "1721686", "3027669735", "3017636737", "2133786", "1221053", "3021599290", "2648988", "1417592", "8043817", "3013875599", "3009265194", "3003418325", "3011120183", "3026612481", "3033536319", "8010047", "3001675293", "3017820152", "3029901716", "3004608878", "1717344", "1722139", "9610773", "8010177", "3013283620", "3010141593", "3010432890", "3015153469", "3002808148", "3015183635", "3010273872", "1721983", "3040335671", "3009750704", "1643817", "3001592626", "3026606306", "3007225330", "1527736", "3010885402", "9710649", "3015224777", "3024490294", "3015612252", "3024021261", "3014479313", "2183744", "3003800159", "3008309062", "1047843", "3004636440", "3007014520", "1018470", "3011823740", "3005075853", "3017619652", "3035387162", "3009116370", "1722447", "3030153385", "3016245399", "3011050570", "3011989923", "3012507533", "3032391", "3014279513", "3013111980", "3009747810", "3016096100", "3010188783", "3013868968", "3010493171", "2648666", "9613895", "3005646850", "3004530184", "9614641", "3013665681", "1319639", "3010594949", "3009350690" ], "fei_number": [ "", "3030733800", "3015540957", "3011024991", "3015967359", "3012494290", "3003076831", "3003724334", "1000160458", "3018094310", "1000518731", "3013188547", "3017196117", "3009941480", "3009380063", "2183715", "3010684280", "1000064530", "3015895145", "1000115735", "3011063460", "3007487007", "3003164255", "3007997036", "3002821504", "3014932737", "3022626486", "3013557562", "3012627460", "3025663926", "3021194552", "3016555232", "2182291", "3006697299", "3009719225", "3016832577", "3014663814", "1928237", "3002807798", "3014635169", "3013077751", "3004111573", "3007713438", "3014461810", "3010408671", "2435119", "3002807314", "1000138054", "1721676", "2011171", "3021970868", "3016607092", "3041274936", "3000204692", "3008837339", "3010760216", "3015173212", "1219930", "3013247477", "3007829657", "1721686", "3027669735", "3017636737", "1221053", "1000117172", "3021599290", "1417592", "3013875599", "3009265194", "3003094851", "1000138491", "3003418325", "3011120183", "3026612481", "3033536319", "3001675293", "3017820152", "3003094575", "3004608878", "1717344", "3002299608", "3013283620", "3010141593", "3010432890", "3015153469", "3003565435", "3002808148", "3015183635", "3010273872", "3003995201", "3002681132", "3040335671", "1643817", "3001592626", "3026606306", "3007225330", "1527736", "3010885402", "3015224777", "3024490294", "3015612252", "3024021261", "1000512168", "3014479313", "2183744", "3003800159", "3002806315", "3008309062", "3002808224", "1047843", "3004636440", "3007014520", "1018470", "3011823740", "3005075853", "3017619652", "3035387162", "3009116370", "3030153385", "3016245399", "3011050570", "3011989923", "3012507533", "1000135560", "3014279513", "3013111980", "3009747810", "3016096100", "1000132435", "3000204775", "3010188783", "3013868968", "3010493171", "2648666", "3002807795", "3005646850", "3004530184", "3013665681", "3010594949", "3009350690", "1000132370" ], "device_name": "Instrument, Ultrasonic Surgical", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "U" } } ] }