Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS ...
FDA Device Recall #Z-1836-2026 — Class II — February 25, 2026
Recall Summary
| Recall Number | Z-1836-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 25, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 19189 units |
Product Description
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
Reason for Recall
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
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
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2235-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2237-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2236-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2234-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2232-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.