medical MODERATE Updated 2026-04-29

Medline Industries, LP recalls Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Nu

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Recalled Product

Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673; 4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817; 5) MTS LEFT HEART KIT SPRINGFIELD R, Model Number: 60031245; 6) MTS PERIPHERAL KIT SPRINGFIELD R, Model Number: 60031247; 7) MTS LEFT HEART KIT-COLISEUM MED, Model Number: 60031928; 8) MTS LEFT HEART KIT -2-CALIFORNIA, Model Number: 60033011; 9) MTS LEFT HEART KIT JOHN MUIR CON, Model Number: 60040273; 10) MTS EP MANIFOLD KIT TEXAS HLTH P, Model Number: 60041268; 11) MTS 3V MANIFOLD KIT-SPARROW HOSP, Model Number: 60050097; 12) MTS LEFT HEART KIT FORT SANDERS, Model Number: 60060387; 13) MTS LEFT HEART KIT-GOOD SAMARITA, Model Number: 60070435; 14) DBD-MTS ANGIO KIT-MOUNT HOOD MED, Model Number: 60070521; 15) MTS LFT HRT KIT-GRAND VIEW PG, Model Number: 60071743; 16) MTS CUSTOM MANIFOLD KIT-INGALLS, Model Number: 60090078; 17) MTS CATH LAB KIT - HEARTLAND PG, Model Number: 60090542; 18) MTS LEFT HEART KIT-W.C.A PG, Model Number: 60100071; 19) MTS MANIFOLD KIT-GENESYS REG MED, Model Number: 60100254; 20) MTS 4V W/PRO STA-ST.JOHNS REG ME, Model Number: 60100439; 21) MTS LEFT HEART KIT JEANES HOSPIT, Model Number: 60101773; 22) MTS LEFT HEART KIT-ST. MARYS OF, Model Number: 60131099; 23) DBD-MTS LEFT HEART KIT-LEHIGH VA, Model Number: 60132653; 24) MTS LEFT HEART KIT (3V DT WASTE), Model Number: 60138326; 25) MTS LF HRT KIT-PRESBYTERIAN UNIV, Model Number: 60160148; 26) MTS LEFT HEART KIT-PENINSULA REG, Model Number: 60160428; 27) MTS LEFT HEART KIT BARNES ST.PET, Model Number: 60161135; 28) MTO OR ENDO KIT - PARK RIDGE HOS, Model Number: 60163618; 29) MTS 3V W/DT-CORPUS CHRISTI M.C., Model Number: 60181531; 30) MTS 3V PERC MANIFOLD KIT WEST. A, Model Number: 60182137; 31) MTO CATH KIT PAMPA REGIONAL MED, Model Number: 60182661; 32) MTO HOPKINS LEFT HEART HOWARD CO, Model Number: 60183662; 33) MTS-CARDIOLOGY KIT-HARLINGEN MED, Model Number: 60184001; 34) MTS PERCEPTOR KIT METHODIST. RIC, Model Number: 60185432; 35) MTS LEFT HEART KIT SADDLEBACK ME, Model Number: 60191312; 36) MTS-CARD MAN KIT MARIAN MED CENT, Model Number: 60194273; 37) LEFT HEART KIT SOUTHERN HILLS HO, Model Number: 60195202; 38) MTS DR KHAIRALLAH LEFT HEART KIT, Model Number: 60200189; 39) MTS,4V,DIAG,KIT UNIV OF CONNECTICUT, Model Number: 60210014; 40) MTO L/H KIT-UNIV OF CLEVELAND -, Model Number: 60210047; 41) MTS LEFT HEART KIT-BAPTIST HLTH, Model Number: 60230503; 42) MTS CAN KIT ACCESSOIRE DIAGNOSTI, Model Number: 60700527; 43) MTS LEFT HEART W/SYRINGE-EMORY U, Model Number: 600503712; 44) MTS ACCESSORY KIT SAINT JOSEPH L, Model Number: 601010412; 45) MTS 3 PORT WHITE KIT LEESBURG RE, Model Number: 601222712; 46) MTS PEDS LFT RT HRT-SUNRISE HO, Model Number: 601905414; 47) MTS LHK ST. LOUIS CARDIO INST, Model Number: 606119072; 48) LHK CENTURA HLTH CORP (ST. ANTHO, Model Number: 6010030361; 49) MTS LHK CHAMPLAIN VALLEY, Model Number: 6010128411; 50) MTS LHK VANDERBILT COFFEE HARTON, Model Number: 6019705921; 51) DBD-LHK EPIC SURGERY CENTER LLC, Model Number: 6020410581; 52) DBD-MTS LHK MS HEALTHCARE MGMT, Model Number: 6061073001; 53) LHK - WESLEY MEDICAL CENTER, Model Number: 6010088152A; 54) IR ANGIOGRAPHY PACK-LF, Model Number: DYNJVB1077D; 55) RADIOLOGY SPECIALS TRAY, Model Number: DYNJVB1302B; 56) ANGIO LEFT HEART PACK, Model Number: DYNJ40632D; 57) ANGIO RIGHT HEART PACK, Model Number: DYNJ40633C; 58) ANGIO TRAY, Model Number: DYNJ43278C; 59) CARDIAC LEG PACK, Model Number: DYNJ44065C; 60) EP PACK, Model Number: DYNJ55512A; 61) VASCULAR PACK, Model Number: DYNJ58522A; 62) PERIPHERAL CATH, Model Number: DYNJ59220C; 63) CARDIAC CATH - NO SYR, Model Number: DYNJ62409A; 64) C V MINOR PACK, Model Number: DYNJ64862B; 65) ENDOVASCULAR PACK, Model Number: DYNJ65926

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Hazard / Issue

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 1) 60021775, UDI-DI: 10193489041385(each), 20193489041382(case), Lot Number: 183372; 2) 60021775, UDI-DI: 10193489041385(each), 20193489041382(case), Lot Number: 185190; 3) 60022026, UDI-DI: 10193489087253(each), 20193489087250(case), Lot Number: 106008; 4) 60022026, UDI-DI: 10193489087253(each), 20193489087250(case), Lot Number: 117378; 5) 60022673, UDI-DI: 10193489041538(each), 20193489041535(case), Lot Number: 176180; 6) 60030817, UDI-DI: 10193489041972(each), 20193489041979(case), Lot Number: 185193; 7) 60031245, UDI-DI: 10193489042214(each), 20193489042211(case), Lot Number: 183374; 8) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 174370; 9) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 184424; 10) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 185080; 11) 60031928, UDI-DI: 10193489042276(each), 20193489042273(case), Lot Number: 185195; 12) 60033011, UDI-DI: 10193489042429(each), 20193489042426(case), Lot Number: 181365; 13) 60040273, UDI-DI: 10193489042832(each), 20193489042839(case), Lot Number: 179872; 14) 60040273, UDI-DI: 10193489042832(each), 20193489042839(case), Lot Number: 183375; 15) 60041268, UDI-DI: 10193489043051(each), 20193489043058(case), Lot Number: 140365; 16) 60041268, UDI-DI: 10193489043051(each), 20193489043058(case), Lot Number: 170084; 17) 60050097, UDI-DI: 10193489043242(each), 20193489043249(case), Lot Number: 176186; 18) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 183376; 19) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 185194; 20) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 187370; 21) 60070435, UDI-DI: 10193489044133(each), 20193489044130(case), Lot Number: 183377; 22) 60070435, UDI-DI: 10193489044133(each), 20193489044130(case), Lot Number: 187371; 23) 60070521, UDI-DI: 10193489044164(each), 20193489044161(case), Lot Number: 185196; 24) 60071743, UDI-DI: 10193489044348(each), 20193489044345(case), Lot Number: 176190; 25) 60090078, UDI-DI: 10193489044829(each), 20193489044826(case), Lot Number: 185197; 26) 60090542, UDI-DI: 10193489044867(each), 20193489044864(case), Lot Number: 181373; 27) 60090542, UDI-DI: 10193489044867(each), 20193489044864(case), Lot Number: 185198; 28) 60100071, UDI-DI: 10193489044959(each), 20193489044956(case), Lot Number: 176193; 29) 60100071, UDI-DI: 10193489044959(each), 20193489044956(case), Lot Number: 185189; 30) 60100254, UDI-DI: 10193489045024(each), 20193489045021(case), Lot Number: 185188; 31) 60100439, UDI-DI: 10193489045130(each), 20193489045137(case), Lot Number: 181369; 32) 60100439, UDI-DI: 10193489045130(each), 20193489045137(case), Lot Number: 185203; 33) 60101773, UDI-DI: 10193489045451(each), 20193489045458(case), Lot Number: 181364; 34) 60131099, UDI-DI: 10193489046717(each), 20193489046714(case), Lot Number: 181370; 35) 60131099, UDI-DI: 10193489046717(each), 20193489046714(case), Lot Number: 185204; 36) 60132653, UDI-DI: 10193489047332(each), 20193489047339(case), Lot Number: 181381; 37) 60138326, UDI-DI: 10193489047653(each), 20193489047650(case), Lot Number: 185205; 38) 60160148, UDI-DI: 10193489048704(each), 20193489048701(case), Lot Number: 183382; 39) 60160148, UDI-DI: 10193489048704(each), 20193489048701(case), Lot Number: 185207; 40) 60160428, UDI-DI: 10193489048773(each), 20193489048770(case), Lot Number: 181100; 41) 60161135, UDI-DI: 10193489049046(each), 20193489049043(case), Lot Number: 177936; 42) 60161135, UDI-DI: 10193489049046(each), 20193489049043(case), Lot Number: 185208; 43) 60163618, UDI-DI: 10193489049251(each), 20193489049258(case), Lot Number: 140392; 44) 60181531, UDI-DI: 10193489049619(each), 20193489049616(case), Lot Number: 185209; 45) 60182137, UDI-DI: 10193489049695(each), 20193489049692(case), Lot Number: 185522; 46) 60182137, UDI-DI: 10193489049695(each), 20193489049692(case), Lot Number: 187343; 47) 60182661, UDI-DI: 10193489049794(each), 20193489049791(case), Lot Number: 176203; 48) 60183662, UDI-DI: 10193489050080(each), 20193489050087(case), Lot Number: 181371; 49) 60184001, UDI-DI: 10193489050110(each), 20193489050117(case), Lot Number: 177939; 50) 60184001, UDI-DI: 10193489050110(each), 20193489050117(case), Lot Number: 185210; 51) 60185432, UDI-DI: 10193489050325(each), 20193489050322(case), Lot Number: 184739; 52) 60191312, UDI-DI: 10193489050820(each), 20193489050827(case), Lot Number: 185212; 53) 60194273, UDI-DI: 10193489051094(each), 20193489051091(case), Lot Number: 133064; 54) 60195202, UDI-DI: 10193489051322(each), 20193489051329(case), Lot Number: 181368; 55) 60195202, UDI-DI: 10193489051322(each), 20193489051329(case), Lot Number: 187374; 56) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 176208; 57) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 181375; 58) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 185213; 59) 60210014, UDI-DI: 10193489051766(each), 20193489051763(case), Lot Number: 187375; 60) 60210047, UDI-DI: 10193489051797(each), 20193489051794(case), Lot Number: 181378; 61) 60230503, UDI-DI: 10193489053098(each), 20193489053095(case), Lot Number: 185214; 62) 60700527, UDI-DI: 10193489057171(each), 20193489057178(case), Lot Number: 185215; 63) 600503712, UDI-DI: 10193489070095(each), 20193489070092(case), Lot Number: 185217; 64) 601010412, UDI-DI: 10193489070613(each), 20193489070610(case), Lot Number: 185220; 65) 601222712, UDI-DI: 10193489070910(each), 20193489070917(case), Lot Number: 176212; 66) 601905414, UDI-DI: 10193489072105(each), 20193489072102(case), Lot Number: 181379; 67) 601905414, UDI-DI: 10193489072105(each), 20193489072102(case), Lot Number: 185221; 68) 606119072, UDI-DI: 10193489073461(each), 20193489073468(case), Lot Number: 106750; 69) 6010030361, UDI-DI: 10193489108033(each), 20193489108030(case), Lot Number: 184480; 70) 6010128411, UDI-DI: 10193489093728(each), 20193489093725(case), Lot Number: 181376; 71) 6010128411, UDI-DI: 10193489093728(each), 20193489093725(case), Lot Number: 185223; 72) 6019705921, UDI-DI: 10193489096156(each), 20193489096153(case), Lot Number: 185352; 73) 6019705921, UDI-DI: 10193489096156(each), 20193489096153(case), Lot Number: 185354; 74) 6020410581, UDI-DI: 10193489131598(each), 20193489131595(case), Lot Number: 155372; 75) 6061073001, UDI-DI: 10193489095692(each), 20193489095699(case), Lot Number: 167702; 76) 6010088152A, UDI-DI: 10193489141276(each), 20193489141273(case), Lot Number: 185224; 77) DYNJVB1077D, UDI-DI: 10198459589270(each), 40198459589271(case), Lot Number: 25KLA735; 78) DYNJVB1302B, UDI-DI: 10195327625429(each), 40195327625420(case), Lot Number: 25LLA560; 79) DYNJVB1302B, UDI-DI: 10195327625429(each), 40195327625420(case), Lot Number: 25KLA369; 80) DYNJ40632D, UDI-DI: 10198459198212(each), 40198459198213(case), Lot Number: 25JML198; 81) DYNJ40633C, UDI-DI: 10198459198229(each), 40198459198220(case), Lot Number: 24KMG184; 82) DYNJ40633C, UDI-DI: 10198459198229(each), 40198459198220(case), Lot Number: 25EMF185; 83) DYNJ43278C, UDI-DI: 10193489957358(each), 40193489957359(case), Lot Number: 25DBU258; 84) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 22ABO333; 85) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 22DBN254; 86) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 22IBJ531; 87) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23ABN017; 88) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23BBI303; 89) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23DBG355; 90) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23FBG335; 91) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23GBR632; 92) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23IBB714; 93) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23JBU288; 94) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24ABA045; 95) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24BBH849; 96) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24EBA787; 97) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24FBN083; 98) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24GBX937; 99) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24IBU804; 100) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24KBU070; 101) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 25ABB637; 102) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 25BBT277; 103) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 25DBL306; 104) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 22HBI765; 105) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24BBE157; 106) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 25EBU657; 107) DYNJ55512A, UDI-DI: 10889942765003(each), 40889942765004(case), Lot Number: 22FBI713; 108) DYNJ55512A, UDI-DI: 10889942765003(each), 40889942765004(case), Lot Number: 22FBR989; 109) DYNJ55512A, UDI-DI: 10889942765003(each), 40889942765004(case), Lot Number: 23DBR938; 110) DYNJ55512A, UDI-DI: 10889942765003(each), 40889942765004(case), Lot Number: 23DBR937; 111) DYNJ58522A, UDI-DI: 10198459135781(each), 40198459135782(case), Lot Number: 25CBC459; 112) DYNJ59220C, UDI-DI: 10198459484551(each), 40198459484552(case), Lot Number: 25JLA710; 113) DYNJ62409A, UDI-DI: 10193489218671(each), 40193489218672(case), Lot Number: 25CBD234; 114) DYNJ64862B, UDI-DI: 10195327053703(each), 40195327053704(case), Lot Number: 24IBJ708; 115) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 21HBB198; 116) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 21IBK707; 117) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 21LBH265; 118) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 22ABZ745; 119) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 22EBO031; 120) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 22FBK919; 121) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 23ABG784; 122) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 23BBM271; 123) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 23DBJ192; 124) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 23EBF015; 125) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 23GBC290; 126) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24BBH874; 127) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24CBD055; 128) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24DBO541; 129) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24FBQ427; 130) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24IBL349; 131) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24KBE756; 132) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24KBR816; 133) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 25DBI909; 134) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 21HBO230; 135) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 23EBS139; 136) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 25GBJ642; 137) DYNJ82863C, UDI-DI: 10198459103315(each), 40198459103316(case), Lot Number: 25CBP219; 138) DYNJ83913D, UDI-DI: 10198459515378(each), 40198459515379(case), Lot Number: 25LMI880; 139) DYNJ85073B, UDI-DI: 10198459167164(each), 40198459167165(case), Lot Number: 25EMF051; 140) DYNJ88292, UDI-DI: 10198459142079(each), 40198459142070(case), Lot Number: 24JBQ452; 141) DYNJ88292, UDI-DI: 10198459142079(each), 40198459142070(case), Lot Number: 25EBR618; 142) DYNJ89865, UDI-DI: 10198459296765(each), 40198459296766(case), Lot Number: 25CBP998; 143) DYNJ906951D, UDI-DI: 10198459132490(each), 40198459132491(case), Lot Number: 25JBR478; 144) DYNJ908389B, UDI-DI: 10198459122903(each), 40198459122904(case), Lot Number: 25GBI395; 145) VASC1068, UDI-DI: 10889942527908(each), 40889942527909(case), Lot Number: 21ABE418; 146) VASC1068, UDI-DI: 10889942527908(each), 40889942527909(case), Lot Number: 21ABA917; 147) VASC1127, UDI-DI: 10889942834273(each), 40889942834274(case), Lot Number: 25HBQ004; 148) VASC1324, UDI-DI: 10195327126773(each), 40195327126774(case), Lot Number: 25FBD245; 149) VASC1509, UDI-DI: 10195327686581(each), 40195327686582(case), Lot Number: 24IBE174; 150) VASC1824, UDI-DI: 10198459435805(each), 40198459435806(case), Lot Number: 25GBT688; 151) 00-399024AC, UDI-DI: 10198459162442(each), 40198459162443(case), Lot Number: 25KMB256; 152) 00-399024AC, UDI-DI: 10198459162442(each), 40198459162443(case), Lot Number: 25HMD974

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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Search Amazon for Medline Kits: 1) →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

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