Recalls affecting South Dakota

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0393-2021

Lot/product code:

Lot: 88528 Exp. 09/2021

Recalling firm:

Noven Pharmaceuticals Inc

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0394-2021

Lot/product code:

Lot: 88530 Exp. 10/2021

Recalling firm:

Noven Pharmaceuticals Inc

FDA has not published a risk classification for this recall yet.

Recall #:

88106

Lot/product code:

CARESCAPE PDM: product codes SA3, SPX; model numbers 2042084-001, 2094504-001, 2016793-002, 2016793-003; Software kits, field replaceable units, and upgrade kits: part numbers 2034826-001, 2034826-002, 2034826-003, 2034826-004, 2034826-005, 2034826-006, 2034826-007, 2034826-008, 2034826-009, 2034826-010, 2034826-011, 2034826-012, 2034826-013, 2031069-010, 2045825-001, 2045825-002, 2045825-004, 2045825-005

Recalling firm:

GE Healthcare, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

88014

Lot/product code:

Affected Serial Numbers: A5B1182002, A5B11Y2005, A5D14X2032, A5A1082001, A5C12Y2017, A5D13Y2025, A5C1412028, S7A1642006, A5D13Y2026, A5F1562034, A5B1192004, A5C1222010, A5C1212009, A5C12X2016, A5G1692038, A5G1642036, A5C1232011, A5C1252012, A5D13Z2027, A5D1492030, A5C1262013, A5E1522033, A5G1692039, A5D14X2031, A5B1192003, A5B11Y2006, A5D1312019, A5G1652037, A5D1362021, A5C1292015, A5D13X2024, A5C1422029, A5D1322020, A5B11Z2007, A5C1212008, A5C12Z2018, A5D1372022

Recalling firm:

Canon Medical System, USA, INC.

FDA has not published a risk classification for this recall yet.

Recall #:

88014

Lot/product code:

Affected Serial Numbers: S3C18Y2032, S3C1892029, S3C1912035, S3C2042045, S3A16Z2007, S3B1782012, S3A1692003, S3C1912036, S3C2012043, S3C1882028, S3C19Z2042, S3B17Y2016, S3C1842019, S3C1912034, S3C18Z2033, S3C2012044, S3C2082046, S3B1762010, S3B1762009, S3C1872025, S3C1932039, S3C1812017, S3C19Z2041, S3C1832018, S3B17X2015, S3A16Z2006, S3C1852021, S3C18X2030, S3C1932040, S3C1922038, S3A16Y2004, S3B1782013, S3C1842020, S3C1882026, S3C1912037, S3B1772011, S3A16Z2005, S3C1882027, S3B1782014

Recalling firm:

Canon Medical System, USA, INC.

FDA has not published a risk classification for this recall yet.

Recall #:

88014

Lot/product code:

Affected serial numbers: U4A12Z2020, S4D1132069, S4A1032017, U4B1492081, U4B1582100, S4A1072035, A4A1222019, S4D1172090, U4A1312024, S4A1072034, S4A1082040, A4A11Z2011, U4A1282003, U4B1442070, U4A1352035, U4B1552097, U4A12X2010, S4C1112065, S4C1112064, S3A0922024, S4E1192094, A4A11Z2009, S3A0972032, S4A09Y2002, S4A09Z2006, U4A1382047, S4A1062031, S3A0972030, U4A12X2011, S4C1112061, U4A13X2054, A4A1222015, U4B1642106, A4A1222017, S4A10X2047, S4A09Z2007, U4B1522092, A4A11X2004, S4D1132074, U4A1312023, S4A1052025, S3A0982035, S3A08Y2014, U4A1312022, S4B10Y2051, U4A1352036, U4A1372046, S4D1142076, U4A1292007, U4B1632105, S4B10Y2052, U4A1352037, U4A12Z2018, U4A1312021, U4B1482077, A4A11X2002, U4B14Y2082, U4A13X2051, S4B10Y2050, A4A1252024, U4B1532094, U4B1652107, S3A0922023, S4B10Z2059, S4A09Z2008, U4A1382049, S4D1142078, L3A08Z2002, U4A12Z2014, S3A0822001, A4A11Z2010, S3A0852004, S3A0892009, A4A11X2003, S3A0882007, S4D1132073, U4A1362039, U4B1462074, U4B1522091, U4A1342033, U4A1342034, U4A12X2009, U4A1412059, U4A1412063, U4A1282004, U4A1352038, U4A12Y2013, U4B14Z2086, S4A1022016, S3A0942027, S4D1162084, U4A1292006, S4A1042023, U4B1512089, A4A11X2001, U4A1342029, S4E1192095, U4A1362041, U4A12Y2012, S4A1032018, S3A0952029, U4A1382050, A4A1242021, S4A1092046, A4A1252023, S3A0982033, U4B15Y2102, S4A09Y2004, S4D1132071, S4D1142075, U4A13Y2056, S4A10X2048, S4A1092043, U4B1522093, A4A1232020, A4A11Y2007, S4D1162087, S4A1012010, U4A1412061, S3A1062029, S4D1172088, S3A0872005, A4A1212013, U4B1482076, S4C1112063, U4B1552098, S4D1152080, S4A1042021, S4B10Z2057, U4A1292008, A4A1222016, U4B1432067, U4B1492080, U4A1362042, S4A1092045, S4A1062028, U4B1452071, A4A1242022, A4A1262025, S4A1082036, S4C1112060, S4D1152081, U4A12Z2019, U4B1512090, S4A1042024, U4A13X2055, S4D1132072, A4A11X2005, U4B15X2101, U4B1482079, S4A1072032, U4A12Z2017, S4A1022013, U4B1612103, S4D1132070, S3A0872006, U4A1322025, U4A1382048, S3A0892008, U4B1612104, S4E1182093, U4A13X2052, U4B1542095, S4A1042020, S4A1082037, U4A12Z2015, S3A0922025, S3A0982034, U4B1452072, S4A09Z2005, U4B1452073, U4B1582099, S4A1022015, U4B14Y2084, S3A08X2010, S4D1162085, S3A08Y2013, S4A1092044, S4B10Y2055, A4A1222018, A4A1222014, S4D1172089, U4B1432066, U4B1442069, U4A13Z2057, L3A08Z2001, S3A09X2041, A4A11Y2008, S4A1062030, S3A08Y2012, U4B1472075, S3A0992038, S3A0952028, S3A09X2040, U4A1362043, S4A1042022, U4B1512087, S4D1162086, U4A1342031, U4A1342032, U4A1362040, S4B10Y2053, S4E1182092, S4C1112066, S4A1082042, U4A12Z2016, S4A1012009, S4A1082038, S3A0972031, S4B10Z2056, U4A1282005, U4B1512088, S4A1052026, S4A1012011, U4B14Z2085, U4A1412060, U4A1332028, U4A13X2053, U4B1442068, U4A1362045, U4B14Y2083, U4B1482078, U4B1422065, S3A0932026, U4A1362044, S4A1082039, U4B1542096, U4A1412062, S4A1012012, U4A1282002, U4A1342030, S4A09Y2003

Recalling firm:

Canon Medical System, USA, INC.

FDA has not published a risk classification for this recall yet.

Recall #:

88014

Lot/product code:

Affected Serial Numbers: D5A2082005, S7B1992017, S5C1912050, S5A1662001, D5A2092007, S5B17X2034, S5B18X2046, S5A17X2033, S5A1742021, D5A2062003, S5C18Y2048, S5A1732019, S5A1732018, S5A17Y2035, S7B1892004, S5B1842043, S7B1962013, S5C1972054

Recalling firm:

Canon Medical System, USA, INC.

FDA has not published a risk classification for this recall yet.

Recall #:

88051

Lot/product code:

Software version number: v07.00, v07.01, v07.18, v07.20, v07.22, v07.24.   UDI No. 12NC No. 05060472440020 989706002081 05060472440013 989706000001 05060472441027 989706000051 05060472441058 989706000101

Recalling firm:

Remote Diagnostic Technologies Ltd.

FDA has not published a risk classification for this recall yet.

Recall #:

89964

Lot/product code:

software release R1.x

Recalling firm:

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA has not published a risk classification for this recall yet.

Recall #:

88013

Lot/product code:

Lot numbers: 20V4001.Z3999, Lot 20V4001.Z4019 and 20V4001.Z411

Recalling firm:

Owen Mumford USA, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

89742

Lot/product code:

Model(s) Azurion R2.1

Recalling firm:

Philips Healthcare

FDA has not published a risk classification for this recall yet.

Recall #:

88216

Lot/product code:

Software VE10B. Serial Numbers: 164138 164159 164033 164287 164282 164210 164183 164184 164311 164142 164071 164328 164034 164318 164244 164242 164306 164155 164189 164271 164277 164173 164292 164231 164057 164054 164055 164080 164132 164329 164072 164088 164190 164333 164025 164026 164027 164338 164094 164241 164326 164267 164186 164068 164121 164157 164019 164152 164161 164013 164069 164213 164073 164257 164293 164263 164298 164060 164083 164113 164021 164066 164124 164125 164279 164075 164074 164084 164086 164098 164028 164153 164330 164295 164234 164321 164270 164275 164315 164163 164158 164053 164171 164134 164253 164188 164063 164064 164299 164300 164105 164160 164024 164049 164240 164227 164228 164018 164022 164250 164061 164187 164115 164322 164269 164303 164204 164205 164211 164212 164216 164196 164168 164319 164201 164202

Recalling firm:

Siemens Medical Solutions USA, Inc

FDA has not published a risk classification for this recall yet.

Recall #:

88240

Lot/product code:

GTIN 07613327005417, Lot Number K03CC50

Recalling firm:

Stryker GmbH

FDA has not published a risk classification for this recall yet.

Recall #:

88240

Lot/product code:

GTIN 04546540715357, Lot Number K03CC4F

Recalling firm:

Stryker GmbH

FDA has not published a risk classification for this recall yet.

Recall #:

88250

Lot/product code:

Lot Numbers: 1730500118 1813600098 1911900076 2002900137 1733300158 1819000139 1915800109 2009300076 1801700131 1822600144 1921700146 2023300126 1804000123 1830300170 1926100253 2027200177 1804500142 1831600080 1933700125 2028200196 1809400131 1910200092 1935100121

Recalling firm:

Covidien, LP

FDA has not published a risk classification for this recall yet.

Recall #:

88250

Lot/product code:

Lot Numbers: 1727100082 1804000124 1908400303 2001400121 1730500134 1805900129 1926100248 2009300116 1732700146 1816400078 1926100292 2023300132 1734700118 1823400098 1931600117 2027200192 1801000131 1902800150

Recalling firm:

Covidien, LP

FDA has not published a risk classification for this recall yet.

Recall #:

88250

Lot/product code:

Lot Numbers: 1708800198 1714400174 1904900098 2009300086

Recalling firm:

Covidien, LP

FDA has not published a risk classification for this recall yet.

Recall #:

88250

Lot/product code:

Lot Numbers: 1733700175 1806600076 1828200123 1930200088 1800300146 1814300196 1828900141 2012100137 1805200088 1822000084 1829500128 2027200247

Recalling firm:

Covidien, LP

FDA has not published a risk classification for this recall yet.

Recall #:

88250

Lot/product code:

Lot Numbers: 1725600117 1807300169 1904900113 2009300115 1729100070 1810400154 1909400116 2019500282 1731200151 1812900134 1920500220 2021000088 1732600132 1814300200 1926100254 2027200198 1734700110 1817100089 1930900078 2028200205 1800300131 1821300123 1930900075 2034400101 1805900127 1824700118 1930900076

Recalling firm:

Covidien, LP

FDA has not published a risk classification for this recall yet.

Recall #:

88250

Lot/product code:

Lot Numbers: 1815000193 1920500218 2014900146 2012100124 1905600053

Recalling firm:

Covidien, LP

FDA has not published a risk classification for this recall yet.

Recall #:

88163

Lot/product code:

Lot 2104007, EXP: 02/2024

Recalling firm:

Southwest Technologies Inc

FDA has not published a risk classification for this recall yet.

Recall #:

88250

Lot/product code:

Lot Numbers: 1726300131 1805900130 1911900083 2019900069 1731900198 1813600105 1926100249 2023300142 1800300137 1827600140 1926100293 2023300118 1802400067 1835100109 2002100137 2034400093

Recalling firm:

Covidien, LP

FDA has not published a risk classification for this recall yet.

Recall #:

88250

Lot/product code:

Lot Numbers: 1725600159 1831000117 1906000012 1910600263 1732700137 1902800146 1908400348 2009300117

Recalling firm:

Covidien, LP

FDA has not published a risk classification for this recall yet.

Recall #:

88250

Lot/product code:

Lot Numbers: 1616800188 1719300113 1828900138 2023300147 1703200130 1816400079 1833800127 2026000048 1713700156 1822000123 2009300120

Recalling firm:

Covidien, LP

FDA has not published a risk classification for this recall yet.

Recall #:

88250

Lot/product code:

Lot Numbers: 1704700210 1822600138 1826200177

Recalling firm:

Covidien, LP