{ "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": "195889", "product_res_number": "Z-0137-2023", "event_date_initiated": "2022-08-03", "event_date_posted": "2022-10-27", "recall_status": "Open, Classified", "res_event_number": "90804", "product_code": "KNW", "k_numbers": [ "K180450" ], "product_description": "CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, CORA1815S/B, CORA1820/A, CORA1820/B, CORA1820S/A, CORA1825/A, CORA1825/B, CORA1825S/A, CORA2010/A, CORA2010/B, CORA2010S/A, CORA2015/A, CORA2015/B, CORA2015S/A, CORA2020/A, CORA2020/B, CORCA1410/A, CORCA1410/B, CORCA1415/A, CORCA1415/B, CORCA1610/A, CORCA1610/B, CORCA1610S/B, CORCA1615/A, CORCA1615/B, CORCA1615S/B, CORCA1810B/A, CORCA1810B/B, CORCA1810SB/A, CORCA1810SB/B, CORCA1815B/A, CORCA1815B/B, CORCA1815SB/A, CORCA1815SB/B, CORCA1820B/A, CORCA1820B/B, CORCA1820SB/A, CORCA1820SB/B, CORCA1825B/A, CORCA1825SB/B, CORCA2010B/A, CORCA2010B/B, CORCA2010SB/A, CORCA2010SB/B, CORCA2015B/A, CORCA2015B/B, CORCA2015SB/A, CORCA2015SB/B, CORCA2020B/A, CORCA2020B/B", "code_info": "Catalog Code-Lot/UDI: CORA1610/B-I2075805, I2093969, I2101330, I2124107, I2233501, I2286703, I2325899/00884450476192;\nCORA1610S/B-I2138037, I2352845/00884450476222;\nCORA1615/B-H1408433, H1462686, I1863888, I2127448, I2170247, I2259080/00884450476253;\nCORA1810/A-H1715532, H1756745, H1767115, H1771762, H1776067, H1784861, H1800979, H1808121, H1825693/00884450316405;\nCORA1810/B-I1781878, I1818817, I1837234, I1843704, I1855418, I1866359, I1952354, I1958525, I1971876, I1990075, I1998862, I2043630, I2070249, I2075810, I2093993, I2114550, I2116110, I2124108, I2127451, I2137798, I2155289, I2206046, I2243065, I2263876, I2263877, I2282032, I2291981, I2297372, I2385808/00884450476116;\nCORA1810S/B-I1877912, I1877916, I1902603, I1971867, I1998851, I2033178, I2070341, I2075809, I2124109, I2127455, I2170248, I2370120/00884450477625;\nCORA1815/A-H1733631, H1734003, H1739133, H1756746, H1771770, H1795481, H1800980, H1807701/00884450316412;\nCORA1815/B-I1821113, I1838444, I1855417, I1920169, I1920191, I1946564, I1952362, I1989173, I1990074, I2033176, I2070349, I2075808, I2093995, I2114555, I2116111, I2124110, I2127456, I2137805, I2170249, I2201366, I2233502, I2263885, I2269827, I2325901, I2349440/00884450477618;\nCORA1815S/A-H1756747, H1784863/00884450316528;\nCORA1815S/B-I1869477, I1874063, I2075806, I2114557, I2127463, I2325902/00884450477601;\nCORA1820/A-H1375632, H1382959, H1718587, H1734004, H1739135, H1756748, H1762731, H1771773, H1771881, H1784864, H1815597/00884450316429;\nCORA1820/B-I1823060, I1971866, I2114564, I2137809, I2170250, I2303053, I2385809/00884450477595;\nCORA1820S/A-H1739136, H1790841/00884450316535;\nCORA1825/A-H1749790, H1762724, H1808022, H1815598/00884450316436;\nCORA1825/B-I1843706, I1958504, I2234738, I2239042/00884450477571;\nCORA1825S/A-H1790845/00884450316542;\nCORA2010/A-H1784872, H1815600/00884450316443;\nCORA2010/B-I1863885, I2201378, I2206047, I2237417/00884450477557;\nCORA2010S/A-H1692834, H1776070/00884450316559;\nCORA2015/A-H1795483/00884450316450;\nCORA2015/B-I1823512, I1860367, I1962715, I2140223, I2243072, I2283710, I2303054, I2330668/00884450477526;\nCORA2015S/A-H1697709, H1771823, H1784884, H1795484/00884450316566;\nCORA2020/A-H1815606/00884450316467;\nCORA2020/B-I1781880, I1971845, I2007291, I2228365/00884450477496;\nCORCA1410/A-H1639707/00884450316580;\nCORCA1410/B-I2244480, I2384730/00884450476284;\nCORCA1415/A-, H1776075/00884450316597;\nCORCA1415/B-I2191846, I2286700, I2318838, I2325906/00884450476314;\nCORCA1610/A-H1428538, H1714401/00884450316603;\nCORCA1610/B-I1971855, I1998714, I2114620, I2170251, I2201382, I2233505, I2318858, I2343154/00884450476338;\nCORCA1610S/B-I1874064, I2010416/00884450476345;\nCORCA1615/A-H1703701/00884450316610;\nCORCA1615/B-I1845903, I1888547, I1920175, I1962716, I1998860, I2103685, I2137221, I2137223, I2170252, I2237426, I2286696, I2297374, I2303056, I2330680, I2385810/00884450476352;\nCORCA1615S/B-I2114626, I2246748/00884450476369;\nCORCA1810B/A-H1718595, H1734012, H1749798, H1756750, H1771846, H1776080, H1782158, H1790850, H1800985, H1808042/00884450316627;\nCORCA1810B/B-I1814729, I1838323, I1843705, I1845904, I1869474, I1877911, I1888548, I1902611, I1920161, I1946561, I1946566, I1958530, I1962714, I1990098, I1990104, I1998856, I2025072, I2070266, I2070374, I2093853, I2101369, I2104884, I2114628, I2114714, I2114715, I2116109, I2124195, I2127511, I2150947, I2150948, I2150949, I2159264, I2165513, I2165514, I2201386, I2221444, I2286695, I2303061, I2330685, I2343157, I2385811/00884450476376;\nCORCA1810SB/A-H1733634, H1800986/00884450316801;\nCORCA1810SB/B-I1862927, I1920180, I2033140, I2114634, I2233507, I2303065, I2330686/00884450476383;\nCORCA1815B/A-H1476238, H1608916, H1714408, H1734014, H1734016, H1743880, H1749800, H1749802, H1762717, H1771848, H1776082, H1782159, H1790847, H1795487, H1807720/00884450316634;\nCORCA1815B/B-I1827256, I1838326, I1843709, I1845905, I1860329, I1860365, I1877914, I1888549, I1902608, I1902609, I1920165, I1920186, I1946560, I1946567, I1952368, I1958533, I1962702, I1971860, I1971861, I1990097, I1990103, I2007293, I2058398, I2061959, I2062021, I2065393, I2075813, I2075839, I2094063, I2098053, I2102664, I2105077, I2114651, I2114652, I2124197, I2127514, I2127515, I2150950, I2150952, I2159275, I2159276, I2170253, I2201393, I2217616, I2281931, I2318869, I2330533, I2330692, I2336279, I2343163, I2349439, I2357134, I2385813, I2385814/00884450476390;\nCORCA1815SB/A-H1714409, H1743881, H1756752, H1762715/00884450316740;\nCORCA1815SB/B-I1838328, I1845906, I1877918, I1958536, I2061956, I2075811, I2093850, I2094072, I2233509, I2325909, I2330694, I2399997/00884450476406;\nCORCA1820B/A-H1718598, H1733635, H1734019, H1749803, H1756754, H1762714, H1771883, H1776084, H1790851, H1807721/00884450316641; \nCORCA1820B/B-I1827257, I1845907, I1902605, I1902607, I1920166, I1946562, I1971929, I1990094, I1998850, I1998858, I2007294, I2094075, I2103689, I2114708, I2124200, I2127516, I2150980, I2159282, I2159283, I2233510, I2286679, I2343166, I2352856/00884450476413;\nCORCA1820SB/A-H1733637/00884450316757;\nCORCA1820SB/B-I2137856, I2325911/00884450476437;\nCORCA1825B/A-H1718603/00884450316658;\nCORCA1825B/B-I1946563, I2137863, I2201410, I2265757, I2325913/00884450476451;\nCORCA1825SB/B-I2156607/00884450476468;\nCORCA2010B/A-H1445217, H1703705, H1708690, H1718606, H1718607, H1749806, H1762738, H1771884, H1807725, H1815614/00884450316665;\nCORCA2010B/B-I18210937/I1845908, I1862929, I1874055, I1877913, I1958538, I1971927, I1990070, I2075817, I2094080, I2114709, I2127519, I2170256, I2217622, I2325922/00884450476475;\nCORCA2010SB/A-H1749807/00884450316771;\nCORCA2010SB/B-I1874058, I1902604, I1998852, I2122957, I2233511/00884450477632;\nCORCA2015B/A-H1624841, H1639711, H1657959, H1697713, H1708691, H1714416, H1718609, H1733639, H1734020, H1743882, H1749810, H1771851, H1776086, H1784915, H1790853, H1807727/00884450316672;\nCORCA2015B/B-I1827258, I1855420, I1862900, I1873128, I1874060, I1888545, I1902614, I1920156, I1952374, I1990072, I1998863, I2070355, I2080473, I2094083, I2114711, I2116112, I2124201, I2127521, I2137868, I2159284, I2191857, I2246760, I2263980, I2287299, I2303068, I2352880, I2370145/00884450477649;\nCORCA2015SB/A-H1662694, H1733642, H1739148, H1771853, H1776087, H1807729, H1815615/00884450316788;\nCORCA2015SB/B-I1827270, I1845912, I1862899, I2080472, I2170257, I2201414/00884450477656;\nCORCA2020B/A-H1662697, H1692861, H1708693, H1718613, H1756755, H1771854, H1776088, H1790855, H1807731/00884450316689;\nCORCA2020B/B, I1827272, I1845913, I1869475, I1874065, I1877915, I1971882, I1990071, I2070361, I2075814, I2114712, I2151307, I2170259, I2201416, I2330716/00884450477663;\nCORCA2020SB/B-I2263985, I2297377/00884450477670;", "firm_fei_number": "1721504", "recalling_firm": "Merit Medical Systems, Inc.", "address_1": "1600 W Merit Pkwy", "city": "South Jordan", "state": "UT", "postal_code": "84095-2416", "additional_info_contact": "801-253-1600", "reason_for_recall": "Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.", "root_cause_description": "Process change control", "action": "On 8/3/2022, recall notices were mailed to customers who were asked to do the following:\n1) Identify affected devices, quarantine, discontinue use and distribution, and return to the recalling firm.\n2) If product was further distributed, share the recall notice with these customers/users.\n3) Complete and return the customer response form.\n\nCustomers with questions can contact Customer Service at 801-208-4381, 6AM-6PM, Mon-Fri.", "product_quantity": "1822", "distribution_pattern": "Worldwide distribution - US National distribution including in the states of FL, IL, OH, PA, CA, WI, VA, AZ, AR, MS, TN, MO, MA, MI, NY, NE, TX, WA, MN, LA, DE, IN, AL, NJ, OR, MD, GA, CT, OK, UT, KS, NC, CO, KY, WV, AK, NV, RI, SC, ND, NH, MT and the countries of Finland, Denmark, United Arab Emirates, Spain, Sweden, Norway, Jordan, Australia, Germany, Austria, Italy, United Kingdom, France, Canada, Mexico, Puerto Rico, Chile, Reunion, Belgium, Switzerland, Japan, South Africa, Qatar, Russian Federation, Hungary, Thailand, Namibia, Colombia, New Zealand, Netherlands, Saudi Arabia, Costa Rica, Oman, Cyprus, Slovenia, Croatia, China.", "openfda": { "k_number": [ "K121181", "K942630", "K212820", "K851836", "K103359", "K222462", "K021137", "K022286", "K113209", "K011206", 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