Recalls affecting South Dakota

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

Recall #:

86697

Lot/product code:

Model: V60 Part Number: 1053615 V60 Ventilator,Intl Opt: None  Serial numbers: 100011125 100021457 100049066 100049185 100049195 100049196 100049200 100122592 100172279 201003463 100011045 100013970 100013971 100015382 100097294 100106739 100109494 100109498 100109499 100109504 100110679 100120770 100036303 100036437 100036446 100036447 100036452 100120864 100085138 100101080 100160827 100006791 100006794 100006805 100007128 100007199 100007208 100007342 100010908 100011086 100011088 100011089 100011090 100011124 100011127 100011187 100013251 100013252 100013253 100013254 100013255 100013256 100013282 100013934 100014019 100014024 100014518 100015338 100015342 100015343 100015389 100015760 100016617 100016618 100016619 100016921 100016927 100016928 100016929 100017340 100017341 100017344 100017350 100017352 100017353 100019976 100020060 100020124 100020748 100020751 100020753 100020755 100020759 100020762 100020763 100021296 100021388 100021390 100021393 100021394 100029331 100029334 100029339 100029452 100029454 100029456 100029458 100029463 100036449 100049075 100049080 100049188 100049190 100049191 100049193 100049194 100052404 100052408 100052409 100067424 100067426 100067427 100067429 100067433 100067436 100067438 100067444 100067446 100068359 100068371 100068373 100068375 100068379 100071520 100071862 100071863 100071866 100071869 100071870 100071876 100071877 100071880 100071920 100073207 100073257 100073264 100074188 100074189 100074190 100074191 100074192 100074193 100074194 100086831 100086892 100087094 100087105 100087162 100087340 100087342 100087347 100087348 100087349 100091936 100091937 100092188 100092191 100092494 100092495 100092500 100092501 100092508 100092509 100100130 100100169 100100287 100100293 100100294 100100307 100100309 100100312 100100313 100100314 100114057 100114442 100114458 100114472 100114531 100114535 100114536 100114537 100114538 100114540 100114543 100114548 100114549 100115200 100115208 100115210 100115211 100115215 100115216 100115419 100118351 100118354 100118540 100118548 100118549 100118555 100118677 100118679 100118683 100118689 100125472 100125474 100125479 100125480 100125482 100125483 100147579 100172259 100172263 100172273 100176020 100176849 100182455 100182464 100184608 100185372 201000881 201000914 201001116 201001140 201001143 201001144 201001149 201002035 201002039 201002613 201002618 201002690 201002693 201002694 201002717 201002718 201002722 201003054 201003058 201003059 201003060 201003068 201003070 201003363 201003364 201003398 201003417 201003437 201003460 201003466 201003468 201003469 201003481 201004370 201009855 201009856 201009857 201009858 201009962 201009981 201009982 201009983 201009986 201009987 201010002 201010003 201010005 201010006 100006795 100007207 100007221 100007282 100007287 100007346 100010966 100010974 100011047 100011049 100011050 100011123 100011191 100014015 100014473 100014515 100014523 100014526 100014895 100015787 100015788 100016614 100016930 100017342 100017347 100017351 100017354 100017358 100021456 100024708 100024884 100024886 100024891 100053604 100053684 100053686 100054414 100055578 100055941 100055948 100055951 100055953 100055954 100056013 100056014 100064508 100071131 100073205 100078691 100078694 100084844 100089453 100089529 100089531 100089533 100089535 100092492 100094393 100101079 100101756 100101848 100101953 100102041 100102051 100106442 100107025 100114542 100114544 100114546 100114550 100118346 100120765 100125467 100125475 100125477 100125927 100125933 100126167 100126168 100126172 100136616 100136630 100136636 100143742 100143745 100148955 100148957 100169087 100172278 100174285 100174287 100174296 100182120 100182436 100182443 100182457 100182461 100182466 100182474 201001947 201002034 201002577 201002578 201002691 201002710 201002712 201002713 201002721 201002723 201002726 201003361 201003415 201003449 201004073 201004074 201004090 201010920 201010922 201010925 201010926 201010931 201010934 100016924 100021453 100024892 100052400 100054410 100064524 100064535 100078387 100078699 100084842 100084848 100092192 100092490 100092499 100097041 100107023 100122587 100122681 100125476 100125929 100136628 100158069 100165942 100169645 100182475 100182478 201004070 201004080 201007450 201009870 201015212 201015217 100006107 100006787 100006788 100006789 100006790 100006792 100006793 100006796 100006797 100006798 100006799 100006800 100006801 100006803 100006804 100006806 100007190 100007196 100007214 100007222 100007223 100007285 100007329 100007330 100007332 100007333 100013250 100014013 100014022 100014774 100014898 100015333 100015380 100015383 100015387 100015790 100015795 100015797 100015799 100016615 100017343 100017345 100020649 100020658 100020668 100020750 100020757 100021209 100021452 100021454 100021455 100021458 100021459 100021690 100021691 100022035 100022036 100024881 100024895 100024898 100049067 100049187 100049189 100052405 100054408 100055950 100055952 100064526 100064527 100064529 100064532 1… (truncated, 9418 characters total — see the official FDA record for the full value)

Recalling firm:

Respironics California, LLC

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

Recall #:

86697

Lot/product code:

Model: V60 Part Number: 1053616 V60 Ventilator, English Opt: None Serial Numbers: 100087733 100087738 100087932 100087999 100088155 100004031 100004071 100004073 100005244 100005350 100005351 100005599 100006209 100006210 100006217 100006406 100006701 100006702 100006881 100006883 100006886 100006888 100006891 100006929 100006933 100006939 100006940 100006941 100009417 100009501 100009512 100009513 100009549 100009550 100009553 100009554 100009556 100009566 100009679 100009760 100009761 100009762 100009768 100009769 100009770 100009777 100009812 100009816 100009854 100010206 100010242 100010390 100010514 100010515 100010517 100010519 100011308 100011343 100011344 100011468 100011740 100011741 100011744 100011749 100011750 100011751 100011754 100011791 100011794 100011799 100011801 100011820 100011821 100011822 100011823 100011824 100011825 100011826 100011827 100011828 100011829 100011830 100011831 100012694 100012884 100012887 100012890 100012891 100013021 100013023 100013027 100013032 100013034 100013083 100013667 100013669 100013791 100014073 100014088 100014142 100014147 100014153 100014283 100014286 100015076 100015209 100015213 100015281 100015667 100016078 100016597 100016599 100016736 100016746 100016747 100016749 100017103 100017258 100017287 100017293 100017301 100017302 100019586 100020214 100020215 100020217 100020219 100020220 100020227 100020312 100020314 100020316 100020317 100020445 100020885 100021037 100021042 100021874 100021877 100021968 100023238 100024476 100024484 100025989 100026618 100026620 100026805 100026806 100026807 100026816 100027758 100029842 100029849 100030985 100031674 100033326 100033327 100033328 100033329 100033330 100033332 100033333 100033334 100033335 100033336 100033338 100033339 100033340 100033342 100033454 100034684 100034703 100035358 100035365 100035742 100035744 100035755 100037043 100037044 100037049 100037051 100037057 100037059 100037061 100037257 100038935 100038936 100038939 100040185 100042229 100042475 100043439 100043440 100044800 100044801 100047830 100048873 100049578 100049922 100050003 100050633 100050634 100050638 100050891 100052079 100052289 100052290 100052639 100052645 100053142 100053143 100053337 100053356 100053971 100055007 100056058 100056891 100056894 100058686 100058693 100058698 100063885 100064427 100064431 100064439 100064682 100064684 100064784 100064787 100065219 100066227 100071766 100072295 100079339 100079474 100080118 100080120 100080121 100080122 100080123 100080124 100080126 100080127 100081004 100084640 100091078 100095091 100095180 100095333 100095545 100095633 100095634 100096642 100096690 100096788 100096789 100097541 100097922 100097924 100097926 100097927 100104724 201001172 201001189 201001254 201001255 201001256 201001259 201001260 201001682 201001683 201001696 201001699 201001700 201001720 201001729 201001808 201001812 201001814 201001823 201001825 201001826 201001827 201001829 201001830 201001843 201001849 201001873 201001884 201001939 201001944 201002117 201002148 201002184 201002193 201002426 201002427 201002443 201002445 201002448 201002552 201002566 201002574 201002587 201002770 201002778 201002834 201002868 201002873 201002894 201002899 201002900 201003014 201003145 201003149 201003179 201003183 201003185 201003187 201003216 201003219 201003233 201003238 201003263 201003266 201003268 201003269 201003272 201003273 201006557 Amended 07/29/2021: US Products that Faceplates will be replaced Model: V60 Part Number: 1053616 V60 Ventilator, English Opt: None Serial Numbers: 100004031 100004071 100004073 100005244 100005350 100005351 100005599 100006209 100006210 100006217 100006406 100006701 100006702 100006881 100006883 100006886 100006888 100006891 100006929 100006933 100006939 100006940 100006941 100009417 100009501 100009512 100009513 100009549 100009550 100009553 100009554 100009556 100009566 100009679 100009760 100009761 100009762 100009768 100009769 100009770 100009777 100009812 100009816 100009854 100010206 100010242 100010390 100010514 100010515 100010517 100010519 100011308 100011343 100011344 100011468 100011740 100011741 100011744 100011749 100011750 100011751 100011754 100011791 100011794 100011799 100011801 100011820 100011821 100011822 100011823 100011824 100011825 100011826 100011827 100011828 100011829 100011830 100011831 100012694 100012884 100012887 100012890 100012891 100013021 100013023 100013027 100013032 100013034 100013083 100013667 100013669 100013791 100014073 100014088 100014142 100014147 100014153 100014283 100014286 100015076 100015209 100015213 100015281 100015667 100016078 100016597 100016599 100016736 100016746 100016747 100016749 100017103 100017258 100017287 100017293 100017301 100017302 100019586 100020214 100020215 100020217 100020219 100020220 100020227 100020312 100020314 100020316 100020317 100020445 100020885 100021037 100021042 100021874 100021877 100021968 100023238 100024476 100024484 100025989 100026618 100026620 100026805 100026806 100026807 100026816 100027758 100029842… (truncated, 6780 characters total — see the official FDA record for the full value)

Recalling firm:

Respironics California, LLC

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

Recall #:

86847

Lot/product code:

Serial numbers CU4.0-01062 CU4.0-01063 CU4.0-01066 CU4.0-01068 CU4.0-01069 CU4.0-01070 CU4.0-01072 CU4.0-01073 CU4.0-01074 CU4.0-01076 CU4.0-01078 CU4.0-01079 CU4.0-01081 CU4.0-01083 CU4.0-01084 CU4.0-01086 CU4.0-01088 CU4.0-01089 CU4.0-01090 CU4.0-01091 CU4.0-01093 CU4.0-01094 CU4.0-01095 CU4.0-01096 CU4.0-01097 CU4.0-01100 CU4.0-01101 CU4.0-01102 CU4.0-01103 CU4.0-01104 CU4.0-01106 CU4.0-01107 CU4.0-01108 CU4.0-01110 CU4.0-01113 CU4.0-01114 CU4.0-01115 CU4.0-01116 CU4.0-01117 CU4.0-01119 CU4.0-01121 CU4.0-01123 CU4.0-01124 CU4.0-01126 CU4.0-01127 CU4.0-01128 CU4.0-01129 CU4.0-01130 CU4.0-01131 CU4.0-01132 CU4.0-01133 CU4.0-01134 CU4.0-01135 CU4.0-01138 CU4.0-01141 CU4.0-01142 CU4.0-01143 CU4.0-01144 CU4.0-01146 CU4.0-01147 CU4.0-01149 CU4.0-01151 CU4.0-01152 CU4.0-01153 CU4.0-01154 CU4.0-01157 CU4.0-01158 CU4.0-01159 CU4.0-01160 CU4.0-01161 CU4.0-01162 CU4.0-01163 CU4.0-01164 CU4.0-01165 CU4.0-01166 CU4.0-01167 CU4.0-01170 CU4.0-01173 CU4.0-01174 CU4.0-01175 CU4.0-01176 CU4.0-01177 CU4.0-01178 CU4.0-01179 CU4.0-01185 CU4.0-01186 CU4.0-01191 CU4.0-01195 CU4.0-01198 CU4.0-01203 CU4.0-01205 CU4.0-01215 CU4.0-01231 CU4.0-01233 CU4.0-01234 CU4.0-01237 CU4.0-01239 CU4.0-01245 CU4.0-01248 CU4.0-01251 CU4.0-01252 CU4.0-01255 CU4.0-01268 CU4.0-01289 CU4.0-01292 CU4.0-01299

Recalling firm:

Boston Scientific Corporation

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

Recall #:

90429

Lot/product code:

GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S

Recalling firm:

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

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC090 20NXAC044

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC092 20NXAC006 20NXAC027

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC056 20LXAC057 20NXAC038 20LXAC041 20LXAC055  Additional affected lots as of 3/17/21: 20NXAC013 20NXAC035

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20NXAC005 20LXAC098 20NXAC037 20NXAC039  Additional affected lots as of 3/17/21: 20NXAC008 20LXAC063

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20NXAC034

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC030 20LXAC084 20NXAC002 20LXAC014 20NXAC018

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC052  Additional affected lot as of 3/17/21: 20LXAC088

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC061 20NXAC036 20LXAC062  Additional affected lots as of 3/17/21: 20LXAC099 20LXAC086 20NXAC014

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC042

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC051

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC034 20LXAC069 20NXAC040

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC070 20LXAC103 20NXAC021 20LXAC100 20LXAC026 20LXAC027 20LXAC028 20LXAC029 20LXAC065 20LXAC067 20LXAC071 20NXAC001 20NXAC019 20NXAC020 20NXAC029  Additional affected lots as of 3/17/21: 20LXAC103 20LXAC082 20LXAC025 20LXAC081 20LXAC083

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC024 20LXAC072 20LXAC073 20LXAC085 20NXAC017 20NXAC030 20LXAC074 20LXAC023 20LXAC104  Additional affected lots as of 3/17/21: 20LXAC066 20LXAC089

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC032 20NXAC003

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC031  Additional affected lots as of 3/17/21: 20NXAC004 20LXAC033 20NXAC003 20LXAC032

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC048 20LXAC053 20LXAC047 20NXAC016 20LXAC094 20NXAC009 20LXAC049 20LXAC054 20NXAC025 20NXAC024  Additional Affected lots as of 3/17/21: 20LXAC076 20LXAC077 20LXAC091 20LXAC101 20NXAC010 20NXAC016

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC097  Additional affected lot as of 3/17/21: 20NXAC033

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC043 20LXAC044 20LXAC045 20LXAC059 20LXAC060 20LXAC079 20LXAC095 20NXAC026  Additional lots as of 3/17/21: 20LXAC078 20NXAC012 20LXAC058 20LXAC096 20NXAC011

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC038 20NXAC032

Recalling firm:

Fresenius Medical Care Holdings, Inc.

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

Recall #:

86734

Lot/product code:

SMS ID / Serial Number  SMS20200126 41F41E7A3011, SMS20200182 41F41E7A5006, SMS20200184 41F41E7A5008, SMS20180073 41F41DD7C006, SMS20180068 41F41DD7C003, SMS20180075 41F41DD7C007, SMS20180349 41F41DD85007, SMS20180350 41F41DD85009, SMS20180351 41F41DD86007, SMS20180448 41F41DD88001, SMS20190308 41F41E798002, SMS20190335 41F41E799002, SMS20190383 41F41E79A010, SMS20200033 41F41E79B001, SMS20200034 41F41E79B005, SMS20200219 41F41E7A6012, SMS20200301 41F41E7A6051, SMS20200339 41F41E7A7006, SMS20190016 41F41DD88010, SMS20190138 41F41DD8B007, SMS20190268 41F41E797001, SMS20190307 41F41E798003, SMS20200211 41F41E7A6005, SMS20200232 41F41E7A6020, SMS20200236 41F41E7A6024, SMS20200244 41F41E7A6025, SMS20200245 41F41E7A6026, SMS20180141 41F41DD83007, SMS20190008 41F41DD88007, SMS20190009 41F41DD88008, SMS20200325 41F41E7A6055, SMS20180076 41F41DD81002, SMS20190212 41F41DD8C012, SMS20200059 41F41E7A1007, SMS20200212 41F41E7A6010, SMS20200279 41F41E7A6041, SMS20200324 41F41E7A7002, SMS20200332 41F41E7A7005, SMS20200332 41F41E7A7005, SMS20190129 41F41DD8A018, SMS20190213 41F41DD8C013, SMS20200095 41F41E7A2004, SMS20200087 41F41E7A2006, SMS20200088 41F41E7A2007, SMS20200116 41F41E7A3002, SMS20200117 41F41E7A3003, SMS20180205 41F41DD83023, SMS20180230 41F41DD84006, SMS20190171 41F41DD8C002, SMS20190045 41F41DD89003, SMS20180374 41F41DD87004, SMS20200159 41F41DD87004, SMS20190189 41F41DD8C008, SMS20180117 41F41DD82008, SMS20180096 41F41DD82009, SMS20180097 41F41DD82010, SMS20180185 41F41DD83019, SMS20200129 41F41E7A4002, SMS20200130 41F41E7A4003, SMS20200131 41F41E7A4004, SMS20200132 41F41E7A4005, SMS20200206 41F41E7A6004, SMS20180242 41F41DD84019, SMS20190076 41F41DD89010, SMS20190113 41F41DD8A009, SMS20190092 41F41DD89013, SMS20200208 41F41E7A6002, SMS20180066 41F41DD7C004, SMS20180067 41F41DD7C005, SMS20190367 41F41E799010, SMS20190075 41F41DD89009, SMS20200096 41F41E7A2005, SMS20200280 41F41E7A6042, SMS20200348 41F41E7A7004, SMS20180115 41E09E963008, SMS20180082 41F41DD81005, SMS20180245 41F41DD85003, SMS20190160 41F41DD8B014, SMS20200165 41F41E7A4016, SMS20200271 41F41E7A6035, SMS20180065 41F41DD7C002, SMS20180104 41F41DD82011, SMS20200021 41F41E79B003, SMS20200040 41F41E7A1006, SMS20200042 41F41E7A1001, SMS20200148 41F41DD81010,, SMS20180129 41F41DD83001, SMS20180130 41F41DD83002, SMS20180131 41F41DD83003, SMS20180132 41F41DD83004, SMS20180133 41F41DD83005, SMS20180158 41F41DD83008, SMS20180159 41F41DD83009, SMS20180177 41F41DD83015, SMS20180178 41F41DD83016, SMS20190344 41F41DD7C003, SMS20180261 41F41DD85005, SMS20180262 41F41DD85006, SMS20200043 41F41E7A1002, SMS20200044 41F41E7A1003, SMS20200067 41F41E7A1004, SMS20200055 41F41E7A1009, SMS20200062 41F41E7A1010, SMS20180206 41F41DD83026, SMS20180237 41F41DD84013, SMS20180238 41F41DD84014, SMS20190003 41F41DD88004, SMS20200240 41F41E7A6029, SMS20200241 41F41E7A6030, SMS20200078 41F41E7A6032, SMS20180077 41F41DD81001, SMS20180078 41F41DD81003, SMS20200022 41F41E79B004, SMS20200227 41F41E7A6016

Recalling firm:

Shimadzu Medical Systems

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

Recall #:

86774

Lot/product code:

Catalog Number: K-ACT Lot Number: 1-19-K-ACT and 2-19-K-ACT

Recalling firm:

Helena Laboratories, Corp.