Recalls affecting Connecticut

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

Recall #:

88056

Lot/product code:

Effected serial range: IH00876 IH01451 and IRH00258xxxx IRH01169xxxx  Note: xxxx in serial number is any number.     UDI: 00630414002026

Recalling firm:

Siemens Healthcare Diagnostics, Inc.

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

Recall #:

88056

Lot/product code:

Effected Serial Range: IM00873 IM01452 and IRM00256xxxx IRM01169xxxx Note: xxxx in serial number is any number.   UDI: 00630414007960

Recalling firm:

Siemens Healthcare Diagnostics, Inc.

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

Recall #:

88089

Lot/product code:

Model Number: LNQ22

Recalling firm:

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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

Recall #:

88120

Lot/product code:

Lot Numbers: 16F16F0057 16F19D0027 16F18B0040 16F19E0157 16F18E0121 16F19F0093 16F18F0058 16F19G0066 16F19C0082

Recalling firm:

Arrow International Inc

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

Recall #:

90490

Lot/product code:

Model 712035 Serial Numbers  21862105 21862107 21862123 21862126 22860027

Recalling firm:

Philips Medical Systems DMC GmbH

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

Recall #:

88120

Lot/product code:

Lot Numbers: 16F20C0035 16F20F0124

Recalling firm:

Arrow International Inc

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

Recall #:

88120

Lot/product code:

Lot Numbers: 16F19J0109

Recalling firm:

Arrow International Inc

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

Recall #:

88120

Lot/product code:

Lot Numbers: 23F20A0230 23F20E0004 23F20E0094

Recalling firm:

Arrow International Inc

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

Recall #:

90490

Lot/product code:

Model 712032 Serial Numbers -  10001088  10001097  10001104  10001112  19000317 10001095  10001102  10001105

Recalling firm:

Philips Medical Systems DMC GmbH

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

Recall #:

90490

Lot/product code:

Model 706100 - Serial Number - 10001002 10001003 10001009 10001012 10001014 10001017 10001019 10001020 10001021 10001023 10001027 10001028 10001030 10001037 10001038 10001039 10001040 10001041 10001042 10001043 10001044 10001047 10001049 10001051 20000079  Model 706110  10001052  10001058  10001062  10001068  10001087 10001057  10001059  10001064

Recalling firm:

Philips Medical Systems DMC GmbH

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

Recall #:

90490

Lot/product code:

Model 712034 Serial Numbers  10001073 10001104 10001108 10001109 10001119 10001126 10001135 10001140 10001144 10001145 10001153 10001156 10001157 10001163 10001170 10001173 10001178 10001179 10001183 10001191 10001192 10001199 10001200 10001201 10001203 10001208 10001210 10001216 10001220 10001231 10001232 10001234 10001235 10001236 10001240 10001241 10001248 10001251 10001261 10001262 10001264 10001270 10001271 10001273 10001275 10001280 21861349 21861369 21861402 21861418 21861456 21861460 21861471 21861475 21861490 21861496 21861497 21861498 21861501 21861502 21861525 21861531 21861542 22860038 22860118

Recalling firm:

Philips Medical Systems DMC GmbH

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

Recall #:

90490

Lot/product code:

Model 712031 Serial Numbers -  10001009 10001111  18000123  19000181 20010235 10001039 17000264 18000263 19000297

Recalling firm:

Philips Medical Systems DMC GmbH

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

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

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: 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: 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 #:

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: 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 #:

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 #:

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 #:

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 #:

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