{ "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": "189610", "product_res_number": "Z-0354-2022", "event_date_initiated": "2021-10-04", "event_date_created": "2021-12-09", "recall_status": "Open, Classified", "res_event_number": "88814", "product_code": "KNW", "k_numbers": [ "K974814" ], "product_description": "SuperCore Biopsy Instrument:\n\nREF/Product Description:\n701114090/SUPERCORE BIOPSY INSTR\t14GA X 9CM;\n701114150/SUPERCORE BIOPSY INSTR\t14GA X 15CM;\n701116090/SUPERCORE BIOPSY INSTR\t16GA X 9CM;\n701118060/SUPERCORE BIOPSY INSTR\t18GA X 6CM;\n701118090/SUPERCORE BIOPSY INSTR\t18GA X 9CM;\n701118150/SUPERCORE BIOPSY INSTR\t18GA X 15CM;\n701118200/SUPERCORE BIOPSY INSTR\t18GA X 20CM;\n701120090/SUPERCORE BIOPSY INSTR\t20GA X 9CM;\n701120150/SUPERCORE BIOPSY INSTR\t20GA X 15CM;\n701120200/SUPERCORE BIOPSY INSTR\t20GA X 20CM;\n701214090/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 14G x 9CM;\n701214150/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 14G x 15CM;\n701216090/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 16G x 9CM;\n701216150/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 16G x 15CM;\n701218090/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 18G x 9CM;\n701218150/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 18G x 15CM;\n701218200/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 18G x 20CM;\n701220090/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 20G x 9CM;\n701220150/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 20G x 15CM;\n701220200/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 20G x 20CM;\n701114090M/SUPERCORE BIOPSY INSTR\t14GA X 9CM-MAMMOTOME;\n701114150M/SUPERCORE BIOPSY INSTR\t14GA X 15CM-MAMMOTOME;\n701116090M/SUPERCORE BIOPSY INSTR\t16GA X 9CM-MAMMOTOME;\nSC 1409/PGI Supercore\t14GA x 9CM;\nSC 1609/PGI Supercore\t16GA x 9CM;\nSC 1806/PGI Supercore\t18GA x 6CM;", "code_info": "REF/Product Description:\n701114090/SUPERCORE BIOPSY INSTR\t14GA X 9CM;\nLot Numbers:\n11364350\n11365643\n11368388\n11371872\n11374998\n11376772\n11378864\n11382837\n11385962\n11389848\n\n701114150/SUPERCORE BIOPSY INSTR\t14GA X 15CM;\nLot Numbers:\n11368389;\n11376773;\n\n701116090/SUPERCORE BIOPSY INSTR\t16GA X 9CM;\nLot Numbers:\n11362716;\n11363320;\n11365935;\n11377634;\n11381340;\n11384192;\n11388461;\n11388552;\n11389139;\n\n701118060/SUPERCORE BIOPSY INSTR\t18GA X 6CM;\nLot Numbers:\n11361702;\n11365788;\n11371012;\n11374235;\n11376598;\n11379722;\n11382768;\n11383890;\n11388656;\n11389138;\n\n701118090/SUPERCORE BIOPSY INSTR\t18GA X 9CM;\nLot Numbers:\n11362759;\n11363229;\n11364420;\n11367439;\n11370106;\n11372917;\n11376074;\n11377430;\n11378217;\n11383193;\n11383785;\n11384243;\n11387238;\n11388864;\n\n701118150/SUPERCORE BIOPSY INSTR\t18GA X 15CM;\nLot Numbers:\n11370107;\n11375663;\n11377819;\n11382602;\n11385139;\n11385965;\n11389140;\n11390503;\n\n701118200/SUPERCORE BIOPSY INSTR\t18GA X 20CM;\nLot Numbers:\n11372225;\n11374410;\n11377431;\n11384193;\n11388505;\n\n701120090/SUPERCORE BIOPSY INSTR\t20GA X 9CM;\nLot Numbers:\n11374411;\n11378865;\n11383280;\n\n701120150/SUPERCORE BIOPSY INSTR\t20GA X 15CM;\nLot Numbers:\n11366252\n11367440;\n11376374;\n11377820;\n11381387;\n11385960;\n\n701120200/SUPERCORE BIOPSY INSTR\t20GA X 20CM;\nLot Numbers:\n11366253;\n11380018;\n11388893;\n\n701214090/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 14G x 9CM;\nLot Numbers:\n11369916;\n11378293;\n11383587;\n11387065;\n\n701214150/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 14G x 15CM;\nLot Numbers:\n11377967;\n11382843;\n\n701216090/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 16G x 9CM;\nLot Numbers:\n11364421;\n11367443;\n11374684;\n11379724;\n11385966;\n11388551;\n\n701216150/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 16G x 15CM;\nLot Numbers:\n11382845;\n11388550;\n11390251;\n\n701218090/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 18G x 9CM;\nLot Numbers:\n11361701;\n11364247;\n11367445;\n11372366;\n11374807;\n11378687;\n11383192;\n11383784;\n11388286;\n\n701218150/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 18G x 15CM;\nLot Numbers:\n11371404;\n11373084;\n11377636;\n11380993;\n11383194;\n11383195;\n11387400;\n11387833;\n11390504;\n\n701218200/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 18G x 20CM;\nLot Numbers:\n11366315;\n11372227;\n11377432;\n11381193;\n11382998;\n11384716;\n\n701220090/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 20G x 9CM;\nLot Numbers:\n11367446;\n11370574;\n11375664;\n11380589;\n11381572;\n11388507;\n\n701220150/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 20G x 15CM;\nLot Numbers:\n11368750;\n11371876;\n11372228;\n11376375;\n11377429;\n11380104;\n11384717;\n11387148;\n\n701220200/SUPERCORE BIOPSY INSTR\tW/COAXIAL - 20G x 20CM;\nLot Numbers:\n11362655;\n11363516;\n11372322;\n11378295;\n11380103;\n11382884;\n11387584;\n\n701114090M/SUPERCORE BIOPSY INSTR\t14GA X 9CM-MAMMOTOME;\nLot Numbers:\n11371356;\n11382375;\n11389615;\n\n701114150M/SUPERCORE BIOPSY INSTR\t14GA X 15CM-MAMMOTOME;\nLot Number:\n11371357;\n\n701116090M/SUPERCORE BIOPSY INSTR\t16GA X 9CM-MAMMOTOME;\nLot Number:\n11371359;\n\nSC 1409/PGI Supercore\t14GA x 9CM;\nLot Numbers:\n11370550;\n11384881;\n\nSC 1609/PGI Supercore\t16GA x 9CM;\nLot Number:\n11370552;\n\nSC 1806/PGI Supercore\t18GA x 6CM;\nLot Numbers:\n11375600;\n11364469;", "firm_fei_number": "1625425", "recalling_firm": "Argon Medical Devices, Inc", "address_1": "1445 Flat Creek Rd", "city": "Athens", "state": "TX", "postal_code": "75751-5002", "additional_info_contact": "Rebecca Ellis\n(469) -731-1410", "reason_for_recall": "Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.", "root_cause_description": "Device Design", "action": "On 09/30/2021, the firm sent an \"Urgent-Product Recall Notice\" letter to customers via US Postal Service Registered Mail informing them that the firm has received complaints regarding the semi-automatic Biopsy instrument coming apart during shipping or prior to use. According to the firm's investigation, the plastic housing and plunger can be separated more easily than normal for the lots manufactured during this time frame.\n\nCustomers are instructed to return all affected product to the Recalling Firm's Athens TX facility using RGA#26683, attention Andrea Wieczor. Mailing address is:\nRGA# 26683\nArgon Medical Devices, Inc.\n1445 Flat Creek Road\nAthens, TX 75751 USA\nAtt: Andrea Wieczor\n\nIn addition, Customers are instructed to complete the response acknowledgement form included with the letter/email and return by fax, mail, or email as soon as possible.\n\nFor questions. contact the Director, Post-Market Experience at email address Brian.Rogers@argonmedical.com, or contact Arbee Cummings at Arbee.Cummings@argonmedical.com or Andrea Wieczor at Andrea.Wieczor@argonmedical.com.\n\n(Updated information 11/2/2021), on 10/28/2021, the firm sent an updated \"Urgent-Product Recall Notice for Additional Lots\" letter via mail informing customers that they are expanding the recall to additional lots (list on the Inventory Sheet attached to recall notice). Again the Recalling Firm is instructing customer to return the affected product (listed on the Inventory Sheet).", "product_quantity": "79,910 devices", "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. The countries of ALB, ARE, ARG, AUS, AUT, BEL, BGD, BRA, CAN, CHE, CHL, CHN, COL, CZE, DEU, ECU, ESP, EST, FRA, GBR, GRC, HKG, HUN, IND, IRN, ISR, ITA, JOR, JPN, MAR, MEX, MYS, NLD, NPL, NZL, PAK, PER, PHL, POL, PRT, SAU, SGP, SRB, THA, TUR, and TWN.", "openfda": { "k_number": [ "K201244", "K982401", "K202012", "K974574", "K033700", "K974794", "K980248", "K052638", "K902066", "K031344", "K102756", "K112411", "K864329", "K042753", "K904658", "K003528", "K880098", "K063697", "K060413", "K063233", "K252681", "K883374", "K093256", "K990645", "K000612", "K944837", "K242029", "K974575", "K901339", "K010400", "K233220", "K223612", "K020987", "K012224", "K203141", "K851837", "K012088", "K170008", "K881956", "K080171", "K171890", "K112945", "K001132", "K051581", "K981166", "K201166", "K980068", "K941256", "K181803", "K953399", "K152989", "K020848", "K902461", "K062832", "K252795", "K162588", "K861267", "K212820", "K033427", "K230015", "K894419", "K040087", "K973496", "K082681", "K954529", 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"3004962788", "3011642792", "1048735", "3015309643", "3018507299", "3007185216", "3000209794", "3007738736", "1000034828", "3016688836", "3001642379", "3000215205", "3008773560", "3007019930", "3009609358", "3015231789", "1220477", "3010041511", "1450662", "3003058448", "3004122598", "3008492462", "3008992312", "1000136478", "3017636737", "1921846", "3009265194", "1219930", "1000434163", "3012936513", "3030733800", "3002808022", "3008002452", "3004598644", "3005496266", "3012494290", "3017210488", "1000484830", "3044026004", "3038611181", "1000114185", "3003272754", "3000126629", "3006788678", "3007748770", "1721504", "3013041594", "1721676", "1000132370", "3014004349", "1000306216", "3008496839", "3003737899", "1000512168", "1219114", "1000305705", "3004749705", "2020394", "3000215273", "3010331645", "3006786907", "3015173212", "3021023752", "1000112137", "3013557562", "3038356900", "3010381606", "1000393132", "1037885", "3007162296", "1222168", "1820334", "3044399745", "3009050824", "3016844398", "3000204727", "3030447506", "3004201275", "3000203000", "1000117748", "1000123143", "2183613", "3013188547", "3000203066", "1018233", "3019807891", "3008599177", "3033858858", "3033589330", "1643817", "3012536737", "3005216725", "3006849754", "3016050940", "2648666", "3006981798", "1000132436", "3007664053", "3015974593", "3005580113", "3010220595", "2246552", "1417485", "3006082230", "1000122656", "3015225571", "3014408997", "2022435", "3003094851", "3009337401", "3003015552", "3010966701", "3010082909", "1000120743", "1221485", "3015142721", "3013875526", "1625685", "3010273872", "3015967359", "3030446844", "3002806603", "3002808445", "3017448139", "3010339638", "3007137598", "3030626857", "3008262715", "2528981", "3014032451", "3003500271", "3014279513" ], "device_name": "Instrument, Biopsy", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1075", "device_class": "2" } } ] }