Recalls affecting Hawaii

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

Recall #:

87446

Lot/product code:

All lot codes

Recalling firm:

Heartware, Inc.

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

Recall #:

87446

Lot/product code:

All lot codes

Recalling firm:

Heartware, Inc.

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

Recall #:

87476

Lot/product code:

All Lot numbers within active shelf life

Recalling firm:

Medtronic Inc.

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

Recall #:

87476

Lot/product code:

All Lot numbers within active shelf life

Recalling firm:

Medtronic Inc.

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

Recall #:

87396

Lot/product code:

49349Q 49350Q 49351Q 49352Q 49799Q 49800Q 49801Q 49802Q 49809Q 49849Q 49850Q 49851Q 50392Q 50393Q 50492Q 50493Q 50494Q 50495Q 50496Q 50497Q 50615Q 50616Q 50868Q 50869Q 50870Q 50871Q 50872Q 50873Q 50874Q 50875Q 50876Q 50877Q 50878Q 50879Q 50880Q 50881Q

Recalling firm:

Covidien Llc

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

Recall #:

87396

Lot/product code:

46966F 47358F 47359F 47360F 47361F 47362F 47363F 47364F 47365F 47366F 47367F 47368F 47369F 47370F 47371F 47783F 48082F 48083F 48084F 48085F 48086F 48087F 48088F 48090F 48091F 48092F 48437F 48438F 48439F 48440F 48441F 48442F 48443F 48444F 48445F 48446F 48447F 48448F 48449F 48781F 48782F 48783F 49068F 49069F 49070F 49071F 49072F 49073F 49074F 49075F 49076F 49077F 49078F 49079F 49080F 49081F 49082F 49083F 49084F 49366F 49367F 49368F 49369F 49370F 49371F 49372F 49373F 49374F 49375F 49376F 49377F 49378F 49379F 49380F 49381F 49382F 49383F 49384F 49385F 49386F 49387F 49388F 49663F 49664F 49665F 49666F 49667F 49668F 49911F 49912F 49913F 49914F 50197F 50198F 50199F 50285F 50286F 50287F 50297F 50298F 50299F 50300F 50301F 50370F 50371F 50372F 50374F 50375F 50376F 50377F 50378F 50379F 50380F 50489F 50490F 50595F 50596F 50597F 50598F 50599F 50600F 50601F 50602F 50603F 50604F 50605F 50606F 50607F 50608F 50609F 50610F 50848F 50849F 50850F 50851F 50852F 50853F 50854F 51184F 51185F 51186F 51187F 51188F 51190F

Recalling firm:

Covidien Llc

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

Recall #:

87476

Lot/product code:

All Lot numbers within active shelf life

Recalling firm:

Medtronic Inc.

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

Recall #:

87804

Lot/product code:

Catalog Codes/Item Number: S1 - 173-1600/PMWS1x; S2 - 173-2600/PMWS2x ; S3 - 173-3600/PMWS3x;  Serial Number Range: 220568 to 272111 manufactured between 08/01/2018 to 11/26/2020

Recalling firm:

James Leckey Design Ltd

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

Recall #:

88206

Lot/product code:

All lot numbers

Recalling firm:

Cellex

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

Recall #:

87579

Lot/product code:

Software version: 5.1 to 5.7.200

Recalling firm:

Fujifilm Medical Systems U.S.A., Inc.

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

Recall #:

87471

Lot/product code:

S/N: 3.1.0.60341 Software: RayCare 3B (3.1.0.60341) UDI: 0735000201028020191220;

Recalling firm:

RAYSEARCH LABORATORIES AB

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

Recall #:

87387

Lot/product code:

Pump Module with Keypad: manufactured January 23, 2019 to December 5, 2019. Pump Module Door Assembly Kit with Keypad: Dated from January 15, 2019 to November 14, 2019.

Recalling firm:

CareFusion 303, Inc.

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

Recall #:

92483

Lot/product code:

Model: WA-4000, 4500, -8000, and -8500

Recalling firm:

p-Chip Corporation

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

Recall #:

87490

Lot/product code:

560BC: GTIN 00885074539386, Serial Numbers: 560B100094, 560B100212, 560B100244, 560B100257, 560B100274, 560B100283, 560B100418, 560B100439, 560B100482   560BC1: GTIN 00613994450326, Serial Numbers: 560B100901, 560B101368  560BCS: GTIN 00613994258236, Serial Numbers: 560B100369, 560B100376, 560B100472, 560B100495, 560B100496  560BCS1:  GTIN: 00613994450463, Serial Numbers: 560B100191, 560B100690, 560B100783, 560B100806, 560B100820, 560B100871, 560B100896, 560B101062, 560B101187, 560B101318, 560B101344, 560B101470, 560B101499, 560B101504, 560B101519, 560B101593, 560B101526   GTIN 00613994526052, Serial Numbers: 560B102610, 560B102725  GTIN 00643169201033, Serial Numbers: 560B101838  GTIN 00643169201651, Serial Numbers: 560B101834  GTIN 00643169315822, Serial Numbers: 560B100127, 560B101694, 560B101700, 560B101805, 560B101976, 560B101996, 560B102080, 560B102118, 560B102185, 560B102194, 560B102204, 560B102210, 560B102215, 560B102265, 560B102336, 560B102426, 560B102493, 560B102518, 560B102547, 560B102559, 560B102598, 560B102761, 560B102762, 560B102763, 560B102764, 560B102765, 560B102766   GTIN 00763000135447, Serial Numbers: 560B102711, 560B102717, 560B102718, 560B102720, 560B102721, 560B102722, 560B102723, 560B102724, 560B102726, 560B102727, 560B102730, 560B102731, 560B102732, 560B102733, 560B102734, 560B102735, 560B102736, 560B102737, 560B102738, 560B102739, 560B102740, 560B102741, 560B102742, 560B102743, 560B102745, 560B102746, 560B102747, 560B102748, 560B102750, 560B102751, 560B102752, 560B102754, 560B102755, 560B102756, 560B102757, 560B102758, 560B102760, 560B102767, 560B102768, 560B102769, 560B102770, 560B102771, 560B102772, 560B102773, 560B102774, 560B102775, 560B102776  GTIN 00763000159412, Serial Numbers: 560B102930, 560B102931, 560B102932, 560B102933, 560B102934  GTIN 00763000236526, Serial Numbers: 560B102778, 560B102779, 560B102780, 560B102781, 560B102782, 560B102783, 560B102784, 560B102785, 560B102786, 560B102787, 560B102788, 560B102789, 560B102790, 560B102792, 560B102793, 560B102794, 560B102795, 560B102796, 560B102797, 560B102798, 560B102799, 560B102800, 560B102801, 560B102802, 560B102803, 560B102804, 560B102805, 560B102806, 560B102807, 560B102809, 560B102810, 560B102811, 560B102812, 560B102813, 560B102815, 560B102817, 560B102818, 560B102819, 560B102820, 560B102821, 560B102822, 560B102823, 560B102824, 560B102825, 560B102826, 560B102827, 560B102828, 560B102829, 560B102830, 560B102831, 560B102832, 560B102833, 560B102834, 560B102835, 560B102836, 560B102837, 560B102838, 560B102839, 560B102840, 560B102841, 560B102842, 560B102843, 560B102844, 560B102845, 560B102846, 560B102847, 560B102848, 560B102849, 560B102850, 560B102851, 560B102852, 560B102853, 560B102854, 560B102855, 560B102856, 560B102857, 560B102858, 560B102859, 560B102860, 560B102861, 560B102862, 560B102863, 560B102864, 560B102865, 560B102866, 560B102867, 560B102868, 560B102869, 560B102870, 560B102871, 560B102872, 560B102873, 560B102874, 560B102875, 560B102876, 560B102877, 560B102878, 560B102879, 560B102880, 560B102882, 560B102883, 560B102884, 560B102885, 560B102886, 560B102887, 560B102888, 560B102889, 560B102890, 560B102891, 560B102892, 560B102893, 560B102894, 560B102895, 560B102896, 560B102897, 560B102898, 560B102899, 560B102900, 560B102901, 560B102902, 560B102903, 560B102907, 560B102908, 560B102909, 560B102910, 560B102912, 560B102913, 560B102914, 560B102915, 560B102916, 560B102917, 560B102918, 560B102919, 560B102920, 560B102921, 560B102922, 560B102923, 560B102924, 560B102925, 560B102926, 560B102927, 560B102928, 560B102929, 560B102946, 560B102947, 560B102948, 560B102949, 560B102950, 560B102951, 560B102952, 560B102953, 560B102954, 560B102955, 560B102956, 560B102957, 560B102958, 560B102959, 560B102960, 560B102961, 560B102962, 560B102963, 560B102964, 560B102965, 560B102966, 560B102967, 560B102968, 560B102969, 560B102970, 560B102971, 560B102972, 560B102973, 560B102974, 560B102975, 560B102976, 560B102977, 560B102978, 560B102979, 560B102980, 560B102981, 560B102982, 560B102983, 560B102984, 560B102985, 560B102986, 560B102987, 560B102988, 560B102989, 560B102990, 560B102991, 560B102992, 560B102993, 560B102994, 560B102995, 560B102996, 560B102997, 560B102998, 560B102999, 560B103000, 560B103001, 560B103002, 560B103003, 560B103004, 560B103005, 560B103006, 560B103007, 560B103008, 560B103009, 560B103010, 560B103011, 560B103012, 560B103013, 560B103014, 560B103015, 560B103016, 560B103017, 560B103018, 560B103019, 560B103020, 560B103021, 560B103022, 560B103023, 560B103024, 560B103025, 560B103026, 560B103027, 560B103028, 560B103029, 560B103031, 560B103032, 560B103033, 560B103034, 560B103035, 560B103036, 560B103037, 560B103038, 560B103039, 560B103040, 560B103041, 560B103042, 560B103043, 560B103044, 560B103045, 560B103046, 560B103047, 560B103048, 560B103049, 560B103050, 560B103051, 560B103052, 560B103053, 560B103054, 560B103055, 560B103057, 560B103058, 560B103059, 560B103060, 560B103061, 560B103062, 560B103069, 560B103070, 560B103071, 560B103072, 560B103073… (truncated, 5144 characters total — see the official FDA record for the full value)

Recalling firm:

Medtronic Perfusion Systems

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

Recall #:

87472

Lot/product code:

Lot number: 75818I; Expiration Date: 05/18/2021

Recalling firm:

ROi CPS LLC

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

Recall #:

87488

Lot/product code:

Software Versions 6.10 and 6.11

Recalling firm:

Siemens Healthcare Diagnostics, Inc.

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

Recall #:

87488

Lot/product code:

Software Versions 6.10 and 6.11 UDI: 00630414019772

Recalling firm:

Siemens Healthcare Diagnostics, Inc.

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

Recall #:

87488

Lot/product code:

Software Versions 6.10 and 6.11

Recalling firm:

Siemens Healthcare Diagnostics, Inc.

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

Recall #:

87488

Lot/product code:

Software Versions 6.10 and 6.11 UDI: 00630414237886

Recalling firm:

Siemens Healthcare Diagnostics, Inc.

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

Recall #:

87488

Lot/product code:

Software Versions 6.10 and 6.11

Recalling firm:

Siemens Healthcare Diagnostics, Inc.

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

Recall #:

87488

Lot/product code:

Software Versions 6.10 and 6.11 UDI: 00630414019789

Recalling firm:

Siemens Healthcare Diagnostics, Inc.

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

Recall #:

87488

Lot/product code:

Software Versions 6.10 and 6.11 UDI: 00630414581989

Recalling firm:

Siemens Healthcare Diagnostics, Inc.

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

Recall #:

87488

Lot/product code:

Software Versions 6.10 and 6.11 UDI: 00630414560045

Recalling firm:

Siemens Healthcare Diagnostics, Inc.

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

Recall #:

87488

Lot/product code:

Software Versions 6.10 and 6.11

Recalling firm:

Siemens Healthcare Diagnostics, Inc.

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

Recall #:

87488

Lot/product code:

Software Versions 6.10 and 6.11

Recalling firm:

Siemens Healthcare Diagnostics, Inc.