Medline Kits Class II Recall - 65 Cardiovascular Procedure Products
Summary
FDA announced a Class II recall of 65 Medline medical device kit products, including cardiovascular procedure kits, angiography packs, and related cardiac catheterization lab kits. The recalling firm initiated the recall on February 25, 2026, with the recall posted on April 17, 2026. Affected products were distributed to various healthcare facilities under multiple model numbers and lot codes.
What changed
FDA issued a Class II recall for 65 Medline medical device kit products, including cardiovascular procedure kits, manifold kits, and cardiac catheterization lab packs. The affected products span 65 different model numbers and numerous lot codes, distributed across various healthcare facilities nationwide.
Healthcare facilities that have received or used these Medline kits should verify whether they have affected product codes and lot numbers in their inventory. Medical device distributors and hospital supply chain managers should check records for the recalled products and coordinate with Medline regarding return or replacement procedures.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Class 2 Device Recall Medline Kits
- Databases
| 510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards |
| CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | |
| New Search | ) |
| | Class 2 Device Recall Medline Kits | |
| Date Initiated by Firm | February 25, 2026 |
|---|---|
| Date Posted | April 17, 2026 |
| Recall Status | Open , Classified |
| Recall Number | Z-1836-2026 |
| Recall Event ID | 98599 |
| Product Classification | Cardiovascular procedure kit - Product Code OEZ |
| 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 |
| 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 |
| FEI Number | 1417592 |
| Recalling Firm/
Manufacturer | Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753 |
| For Additional Information Contact | Haley Barclay
866-359-1704 |
| Manufacturer Reason
for Recall | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| FDA Determined
Cause | No Marketing Application |
| Action | An URGENT MEDICAL DEVICE RECALL dated 2/25/26 was sent to customers.
REQUIRED ACTION:
1. Immediately check your stock for the affected item number(s) and lot number(s) listed in the recall portal. Quarantine all affected product.
2. Complete your response form. List the quantity of affected product you have in inventory on the form. Even if you do not have any affected product, submit the form to
Website link: https://recalls.medline.com Recall Reference #: R-26-020-FGX1
Recall Code: 3. When we receive your response form, we will send over-labels via FedEx overnight to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit.
4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Include your customers quantities on your response form. When we receive your response form, we will send over-labels to provide to your customers.
Any questions? Contact the Recall Department at 866-359-1704 or recalls@medline.com.
*** An Urgent Medical Device Recall notification letter dated 3/2/26 was sent to customers.
This is a follow-up to a Medline notification you may have received on February 25, 2026. New item numbers and lot numbers have been included with this communication. Recipients receiving this notification for the first time were not affected by the original notification.
REQUIRED ACTIONS:
same as for 2/25/26 letter |
| Quantity in Commerce | 19189 units |
| Distribution | US Nationwide distribution. |
| Total Product Life Cycle | TPLC Device Report |
| 1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes. | |
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