Recalls affecting Idaho

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

Recall #:

81957

Lot/product code:

CN80811000 CN80811001 F5N7000106 F5N7000107 F5O7000002 F5O7000024 F5O7000027 F5O7000037 F5O7000078 F5O7000085 F5O7000091 F5O7000093 US10901771 US10901772 US10901773 US10901774 US10901775 US10901776 US10901777 US10901778 US10901779 US10901782 US10901783 US10901784 US10901785 US10901786 US10901787 US10901788 US10901789 US10901790 US10901791 US10901792 US10901793 US10901794 US10901795 US10901796 US10901797 US10901798 US10901799 US10901800 US10901801 US10901802 US10901803 US10901804 US10901805 US10901806 US10901807 US10901808 US10901809 US10901810 US10901811 US10901812 US10901813 US10901814 US10901815 US10901816 US10901817 US10901818 US10901819 US10901821 US10901822 US10901823 US10901824 US10901825 US10901826 US10901829 US10901830 US10901831 US10901832 US10901833 US10901834 US10901835 US10901836 US10901837 US10901838 US10901839 US10901840 US10901841 US10901842 US10901843 US10901844 US10901845 US10901846 US10901847 US10901848 US10901850 US10901851 US10901852 US10901853 US10901854 US10901855 US10901856 US10901857 US10901858 US10901859 US10901860 US10901861 US10901862 US10901863 US10901864 US10901865 US10901866 US10901867 US10901868 US10901869 US10901870 US10901871 US10901872 US10901873 US10901874 US10901887 US10901888 US10901889 US10901890 US10901891 US10901892 US10901893 US10901894 US10901895 US10901896 US10901897 US10901898 US10901899 US10901900 US10901901 US10901902 US10901907 US10901908 US10901909 US10901910 US10901911 US10901912 US10901913 US10901914 US10901915 US10901916 US10901917 US10901918 US10901919 US10901920 US10901921 US10901922 US10901923 US10901924 US10901925 US10901926 US10901927 US10901928 US10901929 US10901930 US10901931 US10901932 US10901933 US10901934 US10901938 US10901939 US10901940 US10901941 US10901942 US10901943 US10901944 US10901945 US10901946 US10901947 US10901948 US10901949 US10901950 US10901951 US10901952 US10901953 US10901954 US10901955 US10901956 US10901957 US10901958 US10901959 US10901960 US10901961 US10901962 US10901963 US10901964 US10901965 US10901966 US10901967 US10901968 US10901969 US10901970 US10901971 US10901972 US10901973 US10901974 US10901975 US10901976 US10901977 US10901978 US10901979 US10901980 US10901981 US10901982 US10901983 US10901984 US10901985 US10901986 US10901987 US10901988 US10901989 US10901990 US10901991 US10901992 US10901993 US10901994 US10901995 US10901996 US10901997 US10901998 US10901999 US10902000 US10902001 US10902002 US10902003 US10902004 US10902005 US10902006 US10902007 US10902008 US10902009 US10902010 US11003987 US11003988 US11003989 US11003990 US11003991 US11003992 US11003993 US11003994 US11003995 US11003996 US11003997 US11003998 US11003999 US11004000 US11004001 US11004002 US11004003 US11004004 US11004005 US11004006 US11004007 US11004008 US11004009 US11004010 US11004011 US11004012 US11004013 US11004014 US11004015 US11004016 US11004017 US11004018 US11004019 US11004020 US11004021 US11004022 US11004024 US11004025 US11004026 US11004027 US11004028 US11004029 US11004030 US11004031 US11004032 US11004033 US11004034 US11004035 US11004036 US11004037 US11004038 US11004039 US11004040 US11004041 US11004042 US11004043 US11004044 US11004045 US11004046 US11004047 US11004048 US11004049 US11004050 US11004051 US11004052 US11004053 US11004054 US11004055 US11004056 US11004057 US11004058 US11004059 US11004060 US11004061 US11004062 US11004063 US11004064 US11004065 US11004066 US11004068 US11004069 US11004070 US11004071 US11004072 US11004073 US11004074 US11004075 US11004076 US11004077 US11004078 US11004079 US11004080 US11004081 US11004082 US11004083 US11004084 US11004085 US11004086 US11004087 US11004088 US11004089 US11004090 US11004091 US11004092 US11004093 US11004094 US11004095 US11004096 US11004097 US11004098 US11004099 US11004100 US11004101 US11004102 US11004103 US11004104 US11004105 US11004106 US11004107 US11004108 US11004109 US11004110 US11004111 US11004112 US11004113 US11004114 US11004115 US11004116 US11004117 US11004118 US11004119 US11004120 US11004121 US11004122 US11004123 US11004124 US11004125 US11004126 US11004127 US11004128 US11004129 US11004130 US11004131 US11004132 US11004133 US11004134 US11004135 US11004136 US11004137 US11004138 US11004139 US11004140 US11004141 US11004142 US11004143 US11004144 US11004145 US11004146 US11004147 US11004148 US11004149 US11004150 US11004151 US11004152 US11004153 US11004154 US11004155 US11004156 US11004157 US11004158 US11004159 US11004161 US11004162 US11004163 US11004164 US11004165 US11004166 US11004167 US11004168 US11004169 US11004170 US11004171 US11004172 US11105738 US11105739 US11105740 US11105741 US11105742 US11105743 US11105744 US11105745 US11105746 US11105747 US11105748 US11105749 US11105750 US11105751 US11105752 US11105753 US11105754 US11105755 US11105756 US11105757 US11105758 US11105759 US11105760 US11105761 US11105762 US11105763 US11105764 US11105765 US11105766 US11105767 US11105768 US11105769 US11105770 US11105771 US11105772 US11105773 US11105774 US11105775 US11105776 US11105777 US11105778 US11105779 US11105780 US11105781 US1110… (truncated, 166197 characters total — see the official FDA record for the full value)

Recalling firm:

Philips North America, LLC

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

Recall #:

81957

Lot/product code:

US31510433 US31630351 US31630352 US31630353 US51510712 US51510713 US61510947 US61630668 US61630669 US81731977 US81731978 US91511381 US91511445 USO1511461

Recalling firm:

Philips North America, LLC

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

Recall #:

82064

Lot/product code:

Kit Lot Numbers: 664891, 666471, 666604 Pack Lot Numbers: 1066489101, 1066647101,1066660401 UDI:  (01)06438147009176(17)190430(10)664891 (01)06438147009176(17)190430(10)666471 (01)06438147009176(17)190430(10)666604

Recalling firm:

PerkinElmer Life and Analytical Sciences, Wallac, OY

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

Recall #:

82064

Lot/product code:

Kit Lot Numbers: 664303 Pack Lot Numbers: 1066430301, 1066430302 UDI: (01)06438147009343(17)190430(10)664303

Recalling firm:

PerkinElmer Life and Analytical Sciences, Wallac, OY

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

Recall #:

82064

Lot/product code:

Kit Lot Numbers: 664670, 666553 Pack Lot Numbers: 1066467001, 1066467002, 1066655301 UDI: (01)06438147009336(17)190430(10)664670 (01)06438147009336(17)190430(10)666553

Recalling firm:

PerkinElmer Life and Analytical Sciences, Wallac, OY

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

Recall #:

82920

Lot/product code:

Software version 1.4, UDI for the software is 03610520562024.

Recalling firm:

Bio-Rad Laboratories, Inc

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

Recall #:

81972

Lot/product code:

All Lots

Recalling firm:

Intuitive Surgical, Inc.

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

Recall #:

81928

Lot/product code:

60850886 60850888 60850885 60850889 60850890 60876468 60760965 60887217 60887219 60887220 60934623 60887218 60934624 60930494 60934625 60972889 60972890 60972892 61014406 61014408 61014410 61014411 61050171 61050172 61078032 61078031 61097633 61139240 61139239 61139241 61139242 61184965 61184964 61184966 61184967 61204586 61204587 61259626 61259627 61259628 61259629 61288501 61369214 61369215 61369216 61369217 61425732 61425734 61425733 61495692 61517743 61495693 61531653 61531655 61704542 61531654 61704656 61713205 61713206 61713208 61713211 61713207 61713209 61713210 61713216 61713217 61713212 61713214 61713213 61713215

Recalling firm:

Edwards Lifesciences, LLC

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

Recall #:

81945

Lot/product code:

ADAPTA, Dual chamber pacemaker (DDD):  (a) Model Number ADD01, GTIN: 00643169708754, All Serial Numbers  (b) Model Number ADDR01, GTIN: 00643169708587, 00643169708594, 00643169708600, 0643169708624, 00643169969711, All Serial Numbers   (c) Model Number ADDR03, GTIN: 00643169708631, 00643169708648, All Serial Numbers  (d) Model Number ADDR06, GTIN: 00643169708655, 00643169708662, All Serial Numbers  (e) Model Number ADDRL1, GTIN: 00643169518247, 00643169708679, 00643169708686, 00643169708709, 00643169969803, All Serial Numbers  (f) Model Number ADDRS1, GTIN: 00643169708716, 00643169708723, 00643169708730, 00643169708747, 00643169969810, All Serial Numbers   (g) Model Number ADVDD01, GTIN: 00643169708761, 00643169708778, 00643169969735, All Serial Numbers

Recalling firm:

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

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

Recall #:

81945

Lot/product code:

Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR):  (a) Model Number SPDR01, GTIN 00643169882959, 00763000109097, All Serial Numbers  (b) Model Number SPDRL1, GTIN 00643169882966, 00763000109103, All Serial Numbers

Recalling firm:

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

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

Recall #:

81945

Lot/product code:

vitatron (implantable pulse generator):  (a) A-series, Model Number: A30A1, GTIN 00643169709331; A60A1, GTIN 00643169709294, All Serial Numbers (b) E-series, Model Number: E50A1, GTIN 00643169709126, 00643169709140; E60A1, GTIN 00643169709164, 00643169709188, All Serial Numbers (c) G-series, Model Numbers: G70A1, GTIN 00643169709249, 00643169709263; G70A2, GTIN 00643169883000, All Serial Numbers (d) Q-series, Model Number: Q50A2, GTIN 00643169883017; Q70A2, GTIN 00643169882980; Q80A2, GTIN 00643169882997, All Serial Numbers

Recalling firm:

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

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

Recall #:

81945

Lot/product code:

ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR):  (a) Model Number ATDR01, GTIN: 00643169882911, 00763000109059, All Serial Numbers  (b) Model Number ATDRL1, GTIN: 00643169882928, 00763000109066, All Serial Numbers  (c) Model Number ATDRS1, GTIN: 00643169882935, 00763000109073, All Serial Numbers

Recalling firm:

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

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

Recall #:

81945

Lot/product code:

RELIA, Dual chamber pacemaker (VDD):  (a) Model Number RED01, GTIN: 00643169709003, All Serial Numbers  (b) Model Number REDR01, GTIN: 00643169708990, 00643169969742, All Serial Numbers  (c) Model Number REVDD01, GTIN: 00643169709010, 00643169969773, All Serial Numbers

Recalling firm:

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

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

Recall #:

81945

Lot/product code:

SENSIA, Dual chamber pacemaker (DDD):  (a) Model Number SED01, GTIN 00643169708914, All Serial Numbers (b) Model Number SEDR01, GTIN 00643169708877, 00643169708891, 00643169969780, All Serial Numbers (c) Model Number SEDRL1, GTIN 00643169708907, All Serial Numbers

Recalling firm:

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

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

Recall #:

81945

Lot/product code:

Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01, GTIN: 00643169708969, 00643169708983, 00643169709072, All Serial Numbers

Recalling firm:

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

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

Recall #:

D-0411-2019

Lot/product code:

327A18001 327A18002

Recalling firm:

Prinston Pharmaceutical Inc

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

Recall #:

D-0413-2019

Lot/product code:

325D18004 325D18005

Recalling firm:

Prinston Pharmaceutical Inc

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

Recall #:

D-0410-2019

Lot/product code:

325B18004

Recalling firm:

Prinston Pharmaceutical Inc

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

Recall #:

D-0409-2019

Lot/product code:

331B18009

Recalling firm:

Prinston Pharmaceutical Inc

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

Recall #:

D-0412-2019

Lot/product code:

327B18008 327B18009

Recalling firm:

Prinston Pharmaceutical Inc

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

Recall #:

83254

Lot/product code:

Revolution CT

Recalling firm:

GE Healthcare, LLC

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

Recall #:

83398

Lot/product code:

All product lots of the Acuson NX3, model # 11235411 containing the following software version: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B;

Recalling firm:

Siemens Medical Solutions USA, Inc.

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

Recall #:

83398

Lot/product code:

All product lots of the Acuson NX3, model # 11235612 containing the following software version: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B;

Recalling firm:

Siemens Medical Solutions USA, Inc.

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

Recall #:

83398

Lot/product code:

All product lots of the Acuson NX2, model # 11284381 containing the following software: VA10A, VA10B,VA10C, VA11A, VA11B, VA11C

Recalling firm:

Siemens Medical Solutions USA, Inc.

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

Recall #:

83398

Lot/product code:

All product lots of the Acuson NX2, model # 11284500 containing the following software: VA10A, VA10B,VA10C, VA11A, VA11B, VA11C

Recalling firm:

Siemens Medical Solutions USA, Inc.