Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model... — FDA record Z-1836-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 25, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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, Mod...
Reason
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Classification
Class II
Recalling firm
Medline Industries, LP
Quantity
19189 units
Agency-reported status
Ongoing
Source record identifier
Z-1836-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicability1) 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: 1019...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide distribution.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Apr 29, 2026
Recall initiation date
Feb 25, 2026
Center classification date
Apr 17, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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