{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "94875", "product_res_number": "Z-0348-2011", "event_date_initiated": "2010-03-15", "event_date_posted": "2010-11-18", "recall_status": "Terminated", "event_date_terminated": "2011-06-21", "res_event_number": "56874", "product_code": "ETD", "product_description": "VT-0101-50 Otological Ventilation Tubes, Catalog Number VT-0101-50, Donaldson, with tab, 1.14 mm Lumen, Silicone, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA.\n\n VT-0204-01\nOtological Ventilation Tubes, Catalog Number VT-0204-01, Shepard, 1.0 mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA.\n\nVT-0406-01\nOtological Ventilation Tubes, Catalog Number VT-0406-01, T-Tube, 5mm x 4mm x 1.14mm Lumen, SI, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA.\n\n\nVT-0503-01\nOtological Ventilation Tubes, Catalog Number VT-0503-01, Armstrong Grommet, 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA.\n\n\nVT-0503-50\nOtological Ventilation Tubes, Catalog Number VT-0503-50, Armstrong Grommet, 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA.\n\n\n VT-0507-01\nOtological Ventilation Tubes, Catalog Number VT-0507-01, Armstrong Grommet w/wire, 1.14mm Lumen, FL, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA.\n\n\nVT0508-50\nOtological Ventilation Tubes, Catalog Number VT-0508-50, Modified Armstrong Grommet 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA.\n\n VT-1002-50\nOtological Ventilation Tubes, Catalog Number VT-1002-50, Collar Button, 1.27mm Lumen, Silicone, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA.\n\n\nVT-1035-01\nOtological Ventilation Tubes, Catalog Number VT-1035-01, Collar Button, 1.5mm Lumen, Titanium, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA.\n\n\nVT1204-01\nOtological Ventilation Tubes, Catalog Number VT-1204-01, Reuter Bobbin 1.14mm , Lumen, FL Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA.\n\n VT-1421-01\nOtological Ventilation Tubes, Catalog Number VT-1421-01, Angled Tab Bobbin 1.27mm Lumen, TI, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA.\n\nET-ABGDT-45\nDistributed By API Anthony products, Inc., ET-ABGDT-45 Armstrong Grommet, 1.14mm Lumen, FP Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes.\n\n ET-GTST-45-12,\nDistributed By API Anthony products, Inc., ET-GTST-45-12, T-tube 12 x 10, 1.14mm Lumen, SI , Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. \n\nET-SPDT-40T, \nDistributed By API Anthony products, Inc., ET-SPDT-40T Shea Parasol w/Tab, 1.0mm Lumen, SI, Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes.\n\nET-TBDT-45\nDistributed By API Anthony products, Inc., ET-TBDT-45 Reuter Bobbin w/c Holes 1.14mm Lumen, FP, Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes.", "code_info": "Model / Lot #: VT-0101-50 / 114449, VT-0204-01 / 113210, VT-0406-01 / 113228, VT-0503-01 / 113243/ 113218 , VT-0503-50 / 113236 , VT-0507-01 / 114538, VT0508-50 / 113788, VT-1002-50 / 113248, VT-1035-01 / 114452, VT1204-01 / 113222, VT-1421-01 / 113431.  Model / Lot #: ET-ABGDT-45 / 114651 ET-GTST-45-12 / 114664 ET-SPDT-40T / 114522 ET-TBDT-45 / 114390", "firm_fei_number": "2183425", "recalling_firm": "Micromedics, Inc.", "address_1": "1270 Eagan Industrial Rd Ste 120 1270 Eagan Industrial Rd", "address_2": "Ste 120", "city": "Eagan", "state": "MN", "postal_code": "55121-1385", "additional_info_contact": "651-452-1977 Ext. 226", "reason_for_recall": "Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product which may cause transmission of disease or infection.", "root_cause_description": "Packaging process control", "action": "Micromedics issued a Product Recall letter dated March 15, 2010 to customers, describing the product being recalled, the product sterility issue, and actions to be taken. The letter advised customers to contact Customer service to return any affected product to Micromedics for replacement.\nCustomers can contact Micromedics at 1-800-624-5662 or 651-452-1977 ext. 226 concerning this recall.", "product_quantity": "VT 213 (1982 pouches); ET 50 (500 pouches)", "distribution_pattern": "Nationwide Distribution in the states of CA, CT, DE, FL, GA, ID, IL, IN, MD, MA, MI, MN, NJ, NY, NC, PA, TX, UT, and WI.\n\nFRANCE, NETHERLANDS, BELGIUM, UNITED KINGDOM, CANADA, ISRAEL, PERU, SPAIN, IRELAND.", "openfda": { "k_number": [ "K965115", "K973226", "K943281", "K062672", "K802587", "K830085", "K972126", "K800727", "K151830", "K882689", "K822366", "K971454", "K812459", "K810705", "K870129", "K011383", "K833910", "K883667", "K980828", "K921923", "K252436", "K954795", "K943847", "K943190", "K943325", "K963727", "K822017", "K791680", "K943849", "K955616", "K000801", "K200952", "K823907", "K991670", "K772066", "K822376", "K233658", "K780956", "K151067", "K974008", "K810704", "K142282", "K953802", "K810703", "K232702", "K852387", "K953993", "K781259", "K822375", "K812460", "K082188", "K903285", "K926462", "K943848", "K960477", "K833909", "K832361", "K904594", "K810702", "K871035", "K781260", "K810706", "K911580", "K760438", "K823910", "K830228", "K932166", "K992222", "K900267", "K895242", "K813616", "K923353", "K910618", "K820510", "K830584", "K971124", "K904597", "K171239", "K221254", "K800728", "K802638", "K071178", "K833246", "K823908", "K974007", "K133921", "K062385", "K961873", "K810701", "K960742", "K760439", "K781258", "K061058", "K971943", "K904592", "K820362", "K955447", "K790216", "K832362", "K981575", "K823909", "K811698", "K853641", "K973740", "K103595", "K936275", "K923887", "K941407", "K250256", "K842637", "K870877", "K781257", "K972400", "K232059", "K961945", "K071150" ], "device_name": "Tube, Tympanostomy", "medical_specialty_description": "Ear, Nose, Throat", "regulation_number": "874.3880", "device_class": "2", "registration_number": [ "3012112259", "8010617", "3012494290", "3012130335", "1519132", "3010610937", "3005255160", "3002807315", "3018094310", "3010487482", "2183744", "3008719017", "1048735", "3024021261", "3002806953", "1928237", "3013233645", "1052728", "1926681", "1057421", "1037007", "3012266672", "3006098219", "3010132111", "3013557562", "3016678045", "3009217531", "3011050570", "3017636737", "3010155661", "1045254", "3043226252", "1317188", "9612501", "3003790304", "3003678543" ], "fei_number": [ "3012112259", "3012494290", "1000113735", "3012130335", "1519132", "3010610937", "3005255160", "3002807315", "3018094310", "3010487482", "6062", "2183744", "3008719017", "1048735", "3024021261", "3002806953", "3003495548", "1928237", "3013233645", "1000022662", "1926681", "1037007", "3012266672", "3006098219", "3010132111", "3013557562", "3016678045", "3009217531", "3011050570", "3017636737", "3010155661", "1045254", "3043226252", "1317188", "3003790304", "3003678543" ] } } ] }