Recalls affecting Hawaii

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

Recall #:

88199

Lot/product code:

UDI (DI#): 07613327278330

Recalling firm:

Stryker Medical Division of Stryker Corporation

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

Recall #:

88199

Lot/product code:

Serial Numbers:  2017000300284  UDI: 07613327322569

Recalling firm:

Stryker Medical Division of Stryker Corporation

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

Recall #:

88199

Lot/product code:

Serial Numbers:  FL23J50576 FL23J50577 FL23J60424 FL23J60627 J32346 J32347 J32348 J32350 J29770  UDI: N/A

Recalling firm:

Stryker Medical Division of Stryker Corporation

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

Recall #:

88199

Lot/product code:

Serial Numbers: 1202033898 1206032470 1406034563 1607037109   UDI (DI#): 07613327282566

Recalling firm:

Stryker Medical Division of Stryker Corporation

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

Recall #:

87942

Lot/product code:

Lot # 115T1035

Recalling firm:

Encore Medical, LP

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 #:

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 SN Range: CM00902 - CM02065  Note: xxxx in serial number is any number.   UDI: 00630414002163

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

Recalling firm:

Philips Medical Systems DMC GmbH

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: 23F20A0230 23F20E0004 23F20E0094

Recalling firm:

Arrow International Inc

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

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 #:

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: 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 #:

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.