| | Class 2 Device Recall Medline Convenience Kits |  |
| Date Initiated by Firm | May 21, 2026 |
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| Date Posted | June 29, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2541-2026 |
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| Recall Event ID |
99162 |
| 510(K)Number | K213481 |
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| Product Classification |
General surgery tray - Product Code LRO
|
| Product | Medline Convenience Kits:
1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520;
2) NO CATH CENTRAL LINE KIT, Model Number: CVI4880B;
3) 20G x 6" ARTERIAL CATHETER KIT, Model Number: ART356;
4) MULTIMED 7FR, 16CM, 3L CVC BUNDLE, Model Number: STCVC03;
5) A-LINE KIT, NO CATH, Model Number: ARTNC217;
6) PRESSURE INJ. CVC INSERTION BUNDLE, Model Number: ECVC1720;
7) DIALYSIS CATHETER INSERTION KIT, Model Number: CVI4815;
8) MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: STCVC04;
9) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520;
10) ARTERIAL LINE TRAY, Model Number: ART350;
11) CVC INSERTION BUNDLE 8.5FR 4L 16CM, Model Number: ECVC6355;
12) UMBILICAL VESSEL INSERTION TRAY, Model Number: UVT980;
13) 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number: ECVC5480;
14) UCLA - FINE NEEDLE BIOPSY, Model Number: P972300A;
15) TRIPLE LUMEN COMPLETE CATH KIT 16CM, Model Number: ECVC825A;
16) 8.5F 4L 20CM CVC + BUNDLE, Model Number: ECVC8640;
17) ULTRA CORE BIOPSY KIT, Model Number: SPEC0291B;
18) 3L 7FR 16CM CVC INSERTION BUNDLE, Model Number: ECVC7605;
19) WATERBURY 3L CVC BUNDLE, Model Number: ECVC7330;
20) 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC7600;
21) VANTEX 8.5FR 2L 16CM CVC BUNDLE-US, Model Number: ECVC8110;
22) FEMORAL ARTERIAL LINE TRAY, Model Number: ART660A;
23) VANTEX 3L, 7FR, 16CM CVC INSERTION BNDL, Model Number: ECVC5370B;
24) STD, VAN, 3L, 7F, 20CM, KIC, Model Number: A3720KIC;
25) PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB;
26) VANTEX 7FR 3L 20CM CVC BUNDLE W/US, Model Number: ECVC8180;
27) NO CATH DIALYSIS KIT, Model Number: ECVC8595;
28) SOFT TISSUE TRAY, Model Number: DYNDA1954A;
30) LACERATION TRAY WITH LIDOCAINE, Model Number: SUT10830A;
31) LACERATION TRAY, Model Number: SUT10520;
32) VANTEX 7F 20CM 3L CVC BUNDLE, Model Number: CMPV7203LBB;
33) VANTEX 7F 16CM TRIPLE LUMEN CVC KIT, Model Number: ECVC8380B;
34) BIOPSY TRAY, Model Number: MNS7065A;
35) STD, INTRO-FLEX INTRODUCER 8.5F, Model Number: I500BF85;
36) A LINE TRAY, Model Number: ART690;
37) 8.5F 16cm DOUBLE LUMEN CVC BUNDLE, Model Number: ECVC5490;
38) VANTEX 8.5FR 16CM 4L CVC BUNDLE, Model Number: ECVC8633;
39) VANTEX PI CVC 7F, 3L, 16CM BUNDLE, Model Number: ECVC6920A;
40) BIOPSY PACK, Model Number: DYNDH1135B;
41) PERCUTANEOUS CHEST TUBE KIT, Model Number: CHT1825;
42) VANTEX 7F 16CM 3L PI CVC BUNDLE, Model Number: ECVC7485;
43) ULTRA SOUND TRAY, Model Number: CVI190;
44) BASIC BIOPSY TRAY, Model Number: SPEC0051;
45) MULTIMED 7F 20CM 3L CVC BUNDLE, Model Number: CMPM7203LBB;
46) TRIPLE LUMEN CVC INSERTION TRAY, Model Number: ECVC1490A;
47) 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number: ECVC3505;
48) LOCAL INFILTRATION TRAY, Model Number: DYNDH1406;
49) VANTEX 7FR 20CM 3L CVC BUNDLE, Model Number: ECVC8632;
50) I & D KIT, Model Number: ID1135A;
51) VANTEX 7FR 3L 20CM CVC BUNDLE, Model Number: ECVC8637;
52) VANTEX CVC BUNDLE, 7 FR 3L 16CM, Model Number: ECVC5080;
53) 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC1970B;
54) VASCULAR ACCESS INSERTION KIT, Model Number: CVI5331;
55) VANTEX 7F 20CM 3L CVC BUNDLE PLUS, Model Number: CMPV7203LBPA;
56) VANTEX 7FR 3L 20CM BUNDLE, Model Number: ECVC6110B;
57) A LINE KIT, 20G, Model Number: ART1303;
58) DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A;
59) 7FR 3L 20CM CVC INSERTION BNDL, Model Number: ECVC7830C;
60) CVC INSERTION KIT 3L-16CM, Model Number: ECVC8616;
61) VANTEX 7FR 3L 20CM CVC BUNDLE US, Model Number: ECVC8320A;
62) VANTEX 7F 20CM TRIPLE LUMEN CVC KIT, Model Number: ECVC8385B;
63) TRIPLE LUMEN BUNDLE, Model Number: ECVC5475;
64) CVC BUNDLE KIT, Model Number: ECVC1700;
65) 3" 20G RADIAL ARTERIAL LINE KIT-ICU, Model Number: ART240C;
66) MAXIMUM PROTECTION CVC INSERTION KIT, Model Number: ECVC1950;
67) CVC TRIPLE LUMEN 7FR PI 16CM BUNDLE, Model Number: ECVC8360;
68) PLASTICS SUTURING SET, Model Number: SUT4065;
69) 3L 7F 20CM CVC INSERTION KIT, Model Number: ECVC8465;
70) ARTHROGRAM TRAY, M |
|---|
| Code Information |
1) ECVC8520, UDI-DI: 10653160375104(each), 00653160375107(case), Lot Number: 2026031790;
2) CVI4880B, UDI-DI: 10653160377191(each), 00653160377194(case), Lot Number: 2026021190;
3) ART356, UDI-DI: 10653160375371(each), 00653160375374(case), Lot Number: 2026011990;
4) STCVC03, UDI-DI: 10653160365235(each), 00653160365238(case), Lot Number: 2026011990;
5) ARTNC217, UDI-DI: 10653160383352(each), 00653160383355(case), Lot Number: 2025121190;
6) ECVC1720, UDI-DI: 10653160365761(each), 00653160365764(case), Lot Number: 2025121990;
7) CVI4815, UDI-DI: 10653160386049(each), 00653160386042(case), Lot Number: 2025121890;
8) STCVC04, UDI-DI: 10653160339342(each), 00653160339345(case), Lot Number: 2025121890;
9) ECVC8520, UDI-DI: 10653160375104(each), 00653160375107(case), Lot Number: 2025122290;
10) ART350, UDI-DI: 10653160362050(each), 00653160362053(case), Lot Number: 2025120890;
11) ECVC6355, UDI-DI: 10653160336396(each), 00653160336399(case), Lot Number: 2025120890;
12) UVT980, UDI-DI: 10653160376705(each), 00653160376708(case), Lot Number: 2025120990;
13) ECVC5480, UDI-DI: 10653160380368(each), 00653160380361(case), Lot Number: 2025122290;
14) P972300A, UDI-DI: 10653160377467(each), 00653160377460(case), Lot Number: 2025120490;
15) ECVC825A, UDI-DI: 10653160387596(each), 00653160387599(case), Lot Number: 2025120490;
16) ECVC8640, UDI-DI: 10653160390848(each), 00653160390841(case), Lot Number: 2025122390;
17) SPEC0291B, UDI-DI: 10653160382003(each), 00653160382006(case), Lot Number: 2026010790;
18) ECVC7605, UDI-DI: 10653160364498(each), 00653160364491(case), Lot Number: 2026010890;
19) ECVC7330, UDI-DI: 10653160364566(each), 00653160364569(case), Lot Number: 2026010790;
20) ECVC7600, UDI-DI: 10653160364443(each), 00653160364446(case), Lot Number: 2026010790;
21) ECVC8110, UDI-DI: 10653160377207(each), 00653160377200(case), Lot Number: 2025120890;
22) ART660A, UDI-DI: 10653160366096(each), 00653160366099(case), Lot Number: 2025120990;
23) ECVC5370B, UDI-DI: 10653160385905(each), 00653160385908(case), Lot Number: 2025120990;
24) A3720KIC, UDI-DI: 10653160376354(each), 00653160376357(case), Lot Number: 2025121090;
25) DYNJ70152MB, UDI-DI: 10653160366157(each), 00653160366150(case), Lot Number: 2025121290;
26) ECVC8180, UDI-DI: 10653160378235(each), 00653160378238(case), Lot Number: 2025121290;
27) ECVC8595, UDI-DI: 10653160378822(each), 00653160378825(case), Lot Number: 2025091890;
28) DYNDA1954A, UDI-DI: 10653160387060(each), 00653160387063(case), Lot Number: 2025102390;
29) ECVC7040A, UDI-DI: 10653160369165(each), 00653160369168(case), Lot Number: 2025102390;
30) SUT10830A, UDI-DI: 10653160386902(each), 00653160386905(case), Lot Number: 2025102390;
31) SUT10520, UDI-DI: 10653160364672(each), 00653160364675(case), Lot Number: 2025102790;
32) CMPV7203LBB, UDI-DI: 10653160360025(each), 00653160360028(case), Lot Number: 2025120190;
33) ECVC8380B, UDI-DI: 10653160382409(each), 00653160382402(case), Lot Number: 2025112590;
34) MNS7065A, UDI-DI: 10193489196566(each), 20193489196563(case), Lot Number: 2025120190;
35) I500BF85, UDI-DI: 10653160378785(each), 00653160378788(case), Lot Number: 2025120290;
36) ART690, UDI-DI: 10653160318019(each), 00653160318012(case), Lot Number: 2025120390;
37) ECVC5490, UDI-DI: 10653160363309(each), 00653160363302(case), Lot Number: 2025120390;
38) ECVC8633, UDI-DI: 10653160390428(each), 00653160390421(case), Lot Number: 2025120490;
39) ECVC6920A, UDI-DI: 10653160389392(each), 00653160389395(case), Lot Number: 2025120890;
40) DYNDH1135B, UDI-DI: 10653160387459(each), 00653160387452(case), Lot Number: 2025120390;
41) CHT1825, UDI-DI: 10653160385660(each), 00653160385663(case), Lot Number: 2025120490;
42) ECVC7485, UDI-DI: 10653160372738(each), 00653160372731(case), Lot Number: 2025120490;
43) CVI190, UDI-DI: 00653160001372(each), 50653160001377(case), Lot Number: 2025120590;
44) SPEC0051, UDI-DI: 10653160387503(each), 00653160387506(case), Lot Number: 2025120290;
45) CMPM7203LBB, UDI-DI: 10653160363798(each), 00653160363791(case), Lot Number: 2025120290;
46) ECVC1490A, UDI-DI: 10653160367147(each), 00653160367140(case), Lot Number: 2025120590;
47) ECVC3505, UDI-DI: 10653160364467(each), 00653160364460(case), Lot Number: 2025120590;
48) DYNDH1406, UDI-DI: 10653160375739(each), 00653160375732(case), Lot Number: 2025121090;
49) ECVC8632, UDI-DI: 10653160390442(each), 00653160390445(case), Lot Number: 2025121290;
50) ID1135A, UDI-DI: 00653160204056(each), 10653160204053(case), Lot Number: 2025120490;
51) ECVC8637, UDI-DI: 10653160389538(each), 00653160389531(case), Lot Number: 2025112690;
52) ECVC5080, UDI-DI: 10653160363194(each), 00653160363197(case), Lot Number: 2025120190;
53) ECVC1970B, UDI-DI: 10653160362975(each), 00653160362978(case), Lot Number: 2025120490;
54) ECVC7675, UDI-DI: 10653160348122(each), 00653160348125(case), Lot Number: 2025112090;
55) CVI5331, UDI-DI: 10653160383017(each), 00653160383010(case), Lot Number: 2025120390;
56) CMPV7203LBPA, UDI-DI: 10653160367529(each), 00653160367522(case), Lot Number: 2025120490;
57) ECVC6110B, UDI-DI: 10653160372691(each), 00653160372694(case), Lot Number: 2025120490;
58) ART1303, UDI-DI: 10653160390268(each), 00653160390261(case), Lot Number: 2025112690;
59) MNS10750A, UDI-DI: 10653160380771(each), 00653160380774(case), Lot Number: 2025112690;
60) CVI190, UDI-DI: 00653160001372(each), 50653160001377(case), Lot Number: 2025112190;
61) ECVC7830C, UDI-DI: 10653160374480(each), 00653160374483(case), Lot Number: 2025112490;
62) ECVC8616, UDI-DI: 10653160386308(each), 00653160386301(case), Lot Number: 2025112490;
63) ECVC8320A, UDI-DI: 10653160374589(each), 00653160374582(case), Lot Number: 2025112590;
64) ECVC8385B, UDI-DI: 10653160382416(each), 00653160382419(case), Lot Number: 2025112590;
65) ECVC5475, UDI-DI: 10653160370406(each), 00653160370409(case), Lot Number: 2025120190;
66) ECVC1700, UDI-DI: 10653160363507(each), 00653160363500(case), Lot Number: 2025112590;
67) ART240C, UDI-DI: 10653160373322(each), 00653160373325(case), Lot Number: 2025112590;
68) ECVC1950, UDI-DI: 10653160375753(each), 00653160375756(case), Lot Number: 2025112690;
69) DYNDL1071A, UDI-DI: 10653160385493(each), 00653160385496(case), Lot Number: 2025112490;
70) ECVC8360, UDI-DI: 10653160370079(each), 00653160370072(case), Lot Number: 2025112490;
71) SUT4065, UDI-DI: 10653160385707(each), 00653160385700(case), Lot Number: 2025112590;
72) ECVC8465, UDI-DI: 10653160372141(each), 00653160372144(case), Lot Number: 2025112090;
73) DYNDH1506, UDI-DI: 10653160382041(each), 00653160382044(case), Lot Number: 2025112490;
74) SPEC4380, UDI-DI: 10653160372561(each), 00653160372564(case), Lot Number: 2025112490;
75) ECVC1376, UDI-DI: 10653160369202(each), 00653160369205(case), Lot Number: 2025112490;
76) DYNDH1526B, UDI-DI: 10193489110180(each), 20193489110187(case), Lot Number: 2025102090;
77) DYNDH1480, UDI-DI: 10653160382805(each), 00653160382808(case), Lot Number: 2025102190;
78) ECVC2930A, UDI-DI: 10653160372646(each), 00653160372649(case), Lot Number: 2025102190;
79) ECVC2940A, UDI-DI: 10653160377863(each), 00653160377866(case), Lot Number: 2025102190;
80) ECVC4985, UDI-DI: 2025102190(each), 10653160387572(case), Lot Number: 00653160387575;
81) MNS8745A, UDI-DI: 2025101690(each), 10653160377009(case), Lot Number: 00653160377002;
82) SUT3710, UDI-DI: 00653160009781(each), 50653160009786(case), Lot Number: 2025102090;
83) MNS5785, UDI-DI: 10653160367406(each), 00653160367409(case), Lot Number: 2025102290;
84) ECVC8180, UDI-DI: 10653160378235(each), 00653160378238(case), Lot Number: 2025112090;
85) ECVC8625, UDI-DI: 10653160388098(each), 00653160388091(case), Lot Number: 2025101090;
86) ECVC4635B, UDI-DI: 10653160388043(each), 00653160388046(case), Lot Number: 2025101490;
87) STCVC3720BP, UDI-DI: 10653160370437(each), 00653160370430(case), Lot Number: 2025101490;
88) ECVC6975A, UDI-DI: 10653160389606(each), 00653160389609(case), Lot Number: 2025101490;
89) ECVC7085, UDI-DI: 10653160338017(each), 00653160338010(case), Lot Number: 2025101490;
90) ECVC8609, UDI-DI: 10653160383505(each), 00653160383508(case), Lot Number: 2025101490;
91) ECVC3210, UDI-DI: 10653160365136(each), 00653160365139(case), Lot Number: 2025102390;
92) DYNJTS0036, UDI-DI: 10653160375678(each), 00653160375671(case), Lot Number: 2025102790;
93) ECVC8340, UDI-DI: 10653160374145(each), 00653160374148(case), Lot Number: 2025102890;
94) ECVC8633, UDI-DI: 10653160390428(each), 00653160390421(case), Lot Number: 2025110690;
95) ECVC6800B, UDI-DI: 10653160387978(each), 00653160387971(case), Lot Number: 2025120890;
96) ART1280A, UDI-DI: 10653160373599(each), 00653160373592(case), Lot Number: 2025101790;
97) CVI3880, UDI-DI: 10653160379041(each), 00653160379044(case), Lot Number: 2025102090;
98) ECVC8025, UDI-DI: 10653160378242(each), 00653160378245(case), Lot Number: 2025101690;
99) STCVC03USGV, UDI-DI: 10653160376934(each), 00653160376937(case), Lot Number: 2025101590;
100) STCVC04USGV, UDI-DI: 10653160376927(each), 00653160376920(case), Lot Number: 2025101590;
101) ECVC1930, UDI-DI: 10653160363026(each), 00653160363029(case), Lot Number: 2025102490;
102) SPEC0034, UDI-DI: 10653160379287(each), 00653160379280(case), Lot Number: 2025102790;
103) ECVC7310A, UDI-DI: 10653160364115(each), 00653160364118(case), Lot Number: 2025101790;
104) ECVC2390, UDI-DI: 10653160375883(each), 00653160375886(case), Lot Number: 2025102090;
105) ECVC6295A, UDI-DI: 10653160383482(each), 00653160383485(case), Lot Number: 2025102090;
106) ECVC8616, UDI-DI: 10653160386308(each), 00653160386301(case), Lot Number: 2025101690;
107) SPEC0052, UDI-DI: 10653160379379(each), 00653160379372(case), Lot Number: 2025101690;
108) ECVC6940, UDI-DI: 10653160375746(each), 00653160375749(case), Lot Number: 2025102390;
109) ECVC7405, UDI-DI: 10653160382683(each), 00653160382686(case), Lot Number: 2025101690;
110) CVI3735, UDI-DI: 10653160362142(each), 00653160362145(case), Lot Number: 2025101490;
111) DYNDH1406, UDI-DI: 10653160375739(each), 00653160375732(case), Lot Number: 2025101790;
112) STCVC02USGV, UDI-DI: 10653160376941(each), 00653160376944(case), Lot Number: 2025101590;
113) ECVC8330A, UDI-DI: 10653160378402(each), 00653160378405(case), Lot Number: 2025102190;
114) ART1170, UDI-DI: 10653160368724(each), 00653160368727(case), Lot Number: 2025101090;
115) ECVC4640B, UDI-DI: 10653160388036(each), 00653160388039(case), Lot Number: 2025101490;
116) ECVC7205B, UDI-DI: 10653160376651(each), 00653160376654(case), Lot Number: 2025101490;
117) P887027, UDI-DI: 10653160383970(each), 00653160383973(case), Lot Number: 2025102290;
118) DYNDH1570, UDI-DI: 10653160375470(each), 00653160375473(case), Lot Number: 2025102490;
119) SUT2710, UDI-DI: 10653160386469(each), 00653160386462(case), Lot Number: 2025102390;
120) ART1255, UDI-DI: 10653160373490(each), 00653160373493(case), Lot Number: 2025100690;
121) ECVC4740A, UDI-DI: 10653160390336(each), 00653160390339(case), Lot Number: 2025102290;
122) ECVC2290B, UDI-DI: 10653160385882(each), 00653160385885(case), Lot Number: 2025102290;
123) HT855, UDI-DI: 00653160013191(each), 50653160013196(case), Lot Number: 2025102290;
124) ECVC8360, UDI-DI: 10653160370079(each), 00653160370072(case), Lot Number: 2025102190;
125) ECVC6355, UDI-DI: 10653160336396(each), 00653160336399(case), Lot Number: 2025100890;
126) STCVC2040B, UDI-DI: 10653160372271(each), 00653160372274(case), Lot Number: 2025120390;
127) CMPV85164LBPA, UDI-DI: 10653160374305(each), 00653160374308(case), Lot Number: 2025101390;
128) CVI3805, UDI-DI: 10653160382911(each), 00653160382914(case), Lot Number: 2025102290;
129) ECVC8638, UDI-DI: 10653160390251(each), 00653160390254(case), Lot Number: 2025102990;
130) STCVC48516BP, UDI-DI: 10653160370529(each), 00653160370522(case), Lot Number: 2025101390;
131) ECVC5370B, UDI-DI: 10653160385905(each), 00653160385908(case), Lot Number: 2025101490;
132) ECVC8545, UDI-DI: 10653160376095(each), 00653160376098(case), Lot Number: 2025101490;
133) DYNDA2663, UDI-DI: 10653160380122(each), 00653160380125(case), Lot Number: 2025101590;
134) ART335, UDI-DI: 10653160313540(each), 00653160313543(case), Lot Number: 2025101690;
135) PICC0020, UDI-DI: 10653160364733(each), 00653160364736(case), Lot Number: 2025101490;
136) ECVC3700, UDI-DI: 10653160376842(each), 00653160376845(case), Lot Number: 2025101590;
137) ECVC3900, UDI-DI: 10653160363996(each), 00653160363999(case), Lot Number: 2025101690;
138) CVI4180, UDI-DI: 10653160379218(each), 00653160379211(case), Lot Number: 2025102190;
139) ECVC8360, UDI-DI: 10653160370079(each), 00653160370072(case), Lot Number: 2025102490;
140) ECVC3400, UDI-DI: 10653160363392(each), 00653160363395(case), Lot Number: 2025102190;
141) ECVC2440B, UDI-DI: 10653160373063(each), 00653160373066(case), Lot Number: 2025112090;
142) ECVC4335A, UDI-DI: 10653160367031(each), 00653160367034(case), Lot Number: 2025112090;
143) ECVC7000A, UDI-DI: 10653160388265(each), 00653160388268(case), Lot Number: 2025100990;
144) ECVC8380B, UDI-DI: 10653160382409(each), 00653160382402(case), Lot Number: 2025100990;
145) ECVC8385B, UDI-DI: 10653160382416(each), 00653160382419(case), Lot Number: 2025100990;
146) ECVC8470, UDI-DI: 10653160372158(each), 00653160372151(case), Lot Number: 2025100990;
147) ECVC7425, UDI-DI: 10653160365051(each), 00653160365054(case), Lot Number: 2025101090;
148) STCVC01, UDI-DI: 10653160364849(each), 00653160364842(case), Lot Number: 2025101090;
149) ECVC825A, UDI-DI: 10653160387596(each), 00653160387599(case), Lot Number: 2025101090;
150) ECVC1685, UDI-DI: 10653160369318(each), 00653160369311(case), Lot Number: 2025101390;
151) STCVC01US, UDI-DI: 10653160367642(each), 00653160367645(case), Lot Number: 2025101090;
152) ECVC8350, UDI-DI: 10653160370062(each), 00653160370065(case), Lot Number: 2025101690;
153) ART356, UDI-DI: 10653160375371(each), 00653160375374(case), Lot Number: 2025101390;
154) ECVC8525, UDI-DI: 10653160375203(each), 00653160375206(case), Lot Number: 2025101090;
155) ECVC6800B, UDI-DI: 10653160387978(each), 00653160387971(case), Lot Number: 2025111090;
156) ECVC7400, UDI-DI: 10653160364924(each), 00653160364927(case), Lot Number: 2025111090;
157) ECVC3505, UDI-DI: 10653160364467(each), 00653160364460(case), Lot Number: 2025093090;
158) SUT19370, UDI-DI: 10653160324225(each), 00653160324228(case), Lot Number: 2025092290;
159) ECVC8585, UDI-DI: 10653160378099(each), 00653160378092(case), Lot Number: 2025090290;
160) STCVC05, UDI-DI: 10653160365242(each), 00653160365245(case), Lot Number: 2025090390;
161) ECVC2205A, UDI-DI: 10653160368427(each), 00653160368420(case), Lot Number: 2025100690;
162) ECVC2735C, UDI-DI: 10653160363231(each), 00653160363234(case), Lot Number: 2025100690;
163) ECVC5385, UDI-DI: 10653160362920(each), 00653160362923(case), Lot Number: 2025100690;
164) ECVC6105, UDI-DI: 10653160379744(each), 00653160379747(case), Lot Number: 2025100690;
165) DYNDH1293B, UDI-DI: 10653160376453(each), 00653160376456(case), Lot Number: 2025092490;
166) ECVC8597, UDI-DI: 10653160383543(each), 00653160383546(case), Lot Number: 2025092590;
167) DYNJ80141MB, UDI-DI: 10653160363040(each), 00653160363043(case), Lot Number: 2025100190;
168) CVI5290, UDI-DI: 10653160378044(each), 00653160378047(case), Lot Number: 2025091890;
169) ECVC6730B, UDI-DI: 10653160372714(each), 00653160372717(case), Lot Number: 2025091890;
170) SUT4065, UDI-DI: 10653160385707(each), 00653160385700(case), Lot Number: 2025091590;
171) ECVC6020A, UDI-DI: 10653160338413(each), 00653160338416(case), Lot Number: 2025100290;
172) ART255, UDI-DI: 10653160367598(each), 00653160367591(case), Lot Number: 2025100690;
173) DYNDH1540C, UDI-DI: 10653160390305(each), 00653160390308(case), Lot Number: 2025100790;
174) SPEC0051, UDI-DI: 10653160387503(each), 00653160387506(case), Lot Number: 2025100790;
175) ECVC1500, UDI-DI: 10653160373780(each), 00653160373783(case), Lot Number: 2025100890;
176) ECVC2335, UDI-DI: 10653160374947(each), 00653160374940(case), Lot Number: 2025100990;
177) A5028VF09, UDI-DI: 10653160362104(each), 00653160362107(case), Lot Number: 2025101090;
178) ART755, UDI-DI: 10653160367505(each), 00653160367508(case), Lot Number: 2025101090;
179) ECVC2065, UDI-DI: 10653160376255(each), 00653160376258(case), Lot Number: 2025100890;
180) ECVC5400, UDI-DI: 10653160365891(each), 00653160365894(case), Lot Number: 2025100890;
181) ECVC1495A, UDI-DI: 10653160363064(each), 00653160363067(case), Lot Number: 2025100990;
182) ECVC8480, UDI-DI: 10653160372622(each), 00653160372625(case), Lot Number: 2025100990;
183) ECVC6675A, UDI-DI: 10653160375951(each), 00653160375954(case), Lot Number: 2025100990;
184) MNS11460, UDI-DI: 10653160323952(each), 00653160323955(case), Lot Number: 2025100690;
185) STCVC2020A, UDI-DI: 10653160380030(each), 00653160380033(case), Lot Number: 2025100890;
186) CHT1880B, UDI-DI: 10653160388333(each), 00653160388336(case), Lot Number: 2025100990;
187) ECVC7970, UDI-DI: 10653160353980(each), 00653160353983(case), Lot Number: 2025100990;
188) ECVC8485, UDI-DI: 10653160373223(each), 00653160373226(case), Lot Number: 2025100990;
189) DYNDH1367, UDI-DI: 10653160385035(each), 00653160385038(case), Lot Number: 2025101090;
190) ECVC4125, UDI-DI: 10653160363453(each), 00653160363456(case), Lot Number: 2025100990;
191) STCVC02US, UDI-DI: 10653160377658(each), 00653160377651(case), Lot Number: 2025100990;
192) ART1070A, UDI-DI: 10653160358329(each), 00653160358322(case), Lot Number: 2025100690;
193) MNS4815, UDI-DI: 10653160380917(each), 00653160380910(case), Lot Number: 2025100990;
194) ECVC6765, UDI-DI: 10653160380276(each), 00653160380279(case), Lot Number: 2025101090;
195) SPEC0091, UDI-DI: 10653160385189(each), 00653160385182(case), Lot Number: 2025101090;
196) STCVC10US, UDI-DI: 10653160343097(each), 00653160343090(case), Lot Number: 2025101090;
197) ID1780, UDI-DI: 10653160257042(each), 00653160257045(case), Lot Number: 2025110790;
198) ECVC105, UDI-DI: 10653160379119(each), 00653160379112(case), Lot Number: 2025110790;
199) CMPV7163LBB, UDI-DI: 10653160364078(each), 00653160364071(case), Lot Number: 2025091990;
200) ECVC7280A, UDI-DI: 10653160389804(each), 00653160389807(case), Lot Number: 2025091890;
201) ECVC4130, UDI-DI: 10653160377955(each), 00653160377958(case), Lot Number: 2025091990;
202) ECVC7385A, UDI-DI: 10653160367161(each), 00653160367164(case), Lot Number: 2025091990;
203) ECVC8020, UDI-DI: 10653160355458(each), 00653160355451(case), Lot Number: 2025091990;
204) STCVC2000, UDI-DI: 10653160380245(each), 00653160380248(case), Lot Number: 2025091990;
205) STCVC3720BPA, UDI-DI: 10653160363767(each), 00653160363760(case), Lot Number: 2025091990;
206) ECVC7325, UDI-DI: 10653160365686(each), 00653160365689(case), Lot Number: 2025100990;
207) ECVC3545, UDI-DI: 10653160387589(each), 00653160387582(case), Lot Number: 2025101090;
208) ECVC6800B, UDI-DI: 10653160387978(each), 00653160387971(case), Lot Number: 2025110690;
209) ECVC1300, UDI-DI: 10653160365792(each), 00653160365795(case), Lot Number: 2025110690;
210) ECVC7605, UDI-DI: 10653160364498(each), 00653160364491(case), Lot Number: 2025103090;
211) ECVC8055A, UDI-DI: 10653160387848(each), 00653160387841(case), Lot Number: 2025102990;
212) ECVC7660, UDI-DI: 10653160367178(each), 00653160367171(case), Lot Number: 2025092690;
213) ECVC1025, UDI-DI: 10653160334682(each), 00653160334685(case), Lot Number: 2025100690;
214) STCVC2015A, UDI-DI: 10653160380320(each), 00653160380323(case), Lot Number: 2025100190;
215) ECVC1720, UDI-DI: 10653160365761(each), 00653160365764(case), Lot Number: 2025091990;
216) ECVC5525A, UDI-DI: 10653160379881(each), 00653160379884(case), Lot Number: 2025091990;
217) ECVC6055A, UDI-DI: 10653160380078(each), 00653160380071(case), Lot Number: 2025091990;
218) ECVC8035, UDI-DI: 10653160357094(each), 00653160357097(case), Lot Number: 2025092290;
219) ECVC7830C, UDI-DI: 10653160374480(each), 00653160374483(case), Lot Number: 2025091990;
220) ECVC8065, UDI-DI: 10653160355502(each), 00653160355505(case), Lot Number: 2025091990;
221) MIDM3120, UDI-DI: 10653160382843(each), 00653160382846(case), Lot Number: 2025092290;
222) PICCM4155, UDI-DI: 10653160370642(each), 00653160370645(case), Lot Number: 2025092490;
223) ID1530, UDI-DI: 10653160372554(each), 00653160372557(case), Lot Number: 2025092690;
224) SPEC0018, UDI-DI: 10080196925025(each), 40080196925026(case), Lot Number: 2025092990;
225) ART740, UDI-DI: 10653160366799(each), 00653160366792(case), Lot Number: 2025100190;
226) SPEC0083B, UDI-DI: 10653160366119(each), 00653160366112(case), Lot Number: 2025093090;
227) I500BF85C, UDI-DI: 10653160378792(each), 00653160378795(case), Lot Number: 2025100690;
228) BT510, UDI-DI: 10653160380757(each), 00653160380750(case), Lot Number: 2025100690;
229) 3K20N18122, UDI-DI: 10653160376330(each), 00653160376333(case), Lot Number: 2025100790;
230) PICCF4155, UDI-DI: 10653160372493(each), 00653160372496(case), Lot Number: 2025100690;
231) ECVC3475, UDI-DI: 10653160382690(each), 00653160382693(case), Lot Number: 2025100690;
232) ECVC745, UDI-DI: 10653160369172(each), 00653160369175(case), Lot Number: 2025103090;
233) ECVC7070B, UDI-DI: 10653160373308(each), 00653160373301(case), Lot Number: 2025103190;
234) ECVC5590B, UDI-DI: 10653160377832(each), 00653160377835(case), Lot Number: 2025091990;
235) ECVC5985B, UDI-DI: 10653160377238(each), 00653160377231(case), Lot Number: 2025091990;
236) ECVC8598, UDI-DI: 10653160383550(each), 00653160383553(case), Lot Number: 2025091990;
237) ECVC6975A, UDI-DI: 10653160389606(each), 00653160389609(case), Lot Number: 2025092990;
238) ECVC1375, UDI-DI: 10653160383741(each), 00653160383744(case), Lot Number: 2025092590;
239) ECVC3070, UDI-DI: 10653160364658(each), 00653160364651(case), Lot Number: 2025100690;
240) ART660A, UDI-DI: 10653160366096(each), 00653160366099(case), Lot Number: 2025100790;
241) DYNDH1570, UDI-DI: 10653160375470(each), 00653160375473(case), Lot Number: 2025091190;
242) ECVC3145, UDI-DI: 10653160363361(each), 00653160363364(case), Lot Number: 2025091590;
243) ECVC7495B, UDI-DI: 10653160380238(each), 00653160380231(case), Lot Number: 2025091290;
244) ECVC7865A, UDI-DI: 10653160364184(each), 00653160364187(case), Lot Number: 2025091590;
245) PICC0010, UDI-DI: 10653160364689(each), 00653160364682(case), Lot Number: 2025093090;
246) DYNDA1616A, UDI-DI: 10888277783249(each), 40888277783240(case), Lot Number: 2025092590;
247) MNS5570, UDI-DI: 10653160387121(each), 00653160387124(case), Lot Number: 2025092290;
248) ECVC2930A, UDI-DI: 10653160372646(each), 00653160372649(case), Lot Number: 2025092390;
249) ECVC2500, UDI-DI: 10653160363651(each), 00653160363654(case), Lot Number: 2025092490;
250) STCVC01USGV, UDI-DI: 10653160376965(each), 00653160376968(case), Lot Number: 2025100290;
251) STCVCNC01, UDI-DI: 10653160375784(each), 00653160375787(case), Lot Number: 2025100190;
252) CMPV7203LBPA, UDI-DI: 10653160367529(each), 00653160367522(case), Lot Number: 2025100190;
253) CMPV7163LBPA, UDI-DI: 10653160367512(each), 00653160367515(case), Lot Number: 2025100190;
254) CMPM7203LBB, UDI-DI: 10653160363798(each), 00653160363791(case), Lot Number: 2025093090;
255) ECVC7840A, UDI-DI: 10653160366676(each), 00653160366679(case), Lot Number: 2025092990;
256) SUT10500, UDI-DI: 10653160377429(each), 00653160377422(case), Lot Number: 2025092990;
257) DYNDA2006, UDI-DI: 10653160383031(each), 00653160383034(case), Lot Number: 2025100390;
258) ECVC4575, UDI-DI: 10653160364061(each), 00653160364064(case), Lot Number: 2025100290;
259) ID1135A, UDI-DI: 00653160204056(each), 10653160204053(case), Lot Number: 2025101490;
260) ART335, UDI-DI: 10653160313540(each), 00653160313543(case), Lot Number: 2025100190;
261) ECVC1685, UDI-DI: 10653160369318(each), 00653160369311(case), Lot Number: 2025092390;
262) ECVC2290B, UDI-DI: 10653160385882(each), 00653160385885(case), Lot Number: 2025092390;
263) ECVC6920A, UDI-DI: 10653160389392(each), 00653160389395(case), Lot Number: 2025091190;
264) ART1290, UDI-DI: 10653160378679(each), 00653160378672(case), Lot Number: 2025091290;
265) ART1005, UDI-DI: 10653160387602(each), 00653160387605(case), Lot Number: 2025091590;
266) I500BF85C, UDI-DI: 10653160378792(each), 00653160378795(case), Lot Number: 2025091690;
267) ECVC7485, UDI-DI: 10653160372738(each), 00653160372731(case), Lot Number: 2025091890;
268) STCVC04, UDI-DI: 10653160339342(each), 00653160339345(case), Lot Number: 2025091890;
269) SUT14745A, UDI-DI: 10653160383987(each), 00653160383980(case), Lot Number: 2025091290;
270) ECVC3155, UDI-DI: 10653160364559(each), 00653160364552(case), Lot Number: 2025091590;
271) SPEC4380, UDI-DI: 10653160372561(each), 00653160372564(case), Lot Number: 2025091790;
272) ECVC8400, UDI-DI: 10653160367987(each), 00653160367980(case), Lot Number: 2025091890;
273) ECVC8515, UDI-DI: 10653160375555(each), 00653160375558(case), Lot Number: 2025091890;
274) ECVC8180, UDI-DI: 10653160378235(each), 00653160378238(case), Lot Number: 2025091990;
275) ECVC8616, UDI-DI: 10653160386308(each), 00653160386301(case), Lot Number: 2025091990;
276) MNS13395, UDI-DI: 10653160347897(each), 00653160347890(case), Lot Number: 2025092590;
277) MNS4560A, UDI-DI: 00653160189049(each), 10653160189046(case), Lot Number: 2025092690;
278) ECVC6970A, UDI-DI: 10653160389378(each), 00653160389371(case), Lot Number: 2025091790;
279) CVI4505, UDI-DI: 10653160319047(each), 00653160319040(case), Lot Number: 2025091590;
280) ECVC1376, UDI-DI: 10653160369202(each), 00653160369205(case), Lot Number: 2025091590;
281) MIDM4220, UDI-DI: 10653160384533(each), 00653160384536(case), Lot Number: 2025091290;
282) ART335, UDI-DI: 10653160313540(each), 00653160313543(case), Lot Number: 2025091690;
283) SUT12960, UDI-DI: 10653160365174(each), 00653160365177(case), Lot Number: 2025091690;
284) ART970A, UDI-DI: 10653160361701(each), 00653160361704(case), Lot Number: 2025091790;
285) DT19810, UDI-DI: 10653160368755(each), 00653160368758(case), Lot Number: 2025091990;
286) DYNDL1071A, UDI-DI: 10653160385493(each), 00653160385496(case), Lot Number: 2025091790;
287) PICC0019, UDI-DI: 10653160364757(each), 00653160364750(case), Lot Number: 2025091190;
288) SUT6525, UDI-DI: 00653160003857(each), 50653160003852(case), Lot Number: 2025092990;
289) ECVC8611A, UDI-DI: 10653160387404(each), 00653160387407(case), Lot Number: 2025092290;
290) ECVC8045, UDI-DI: 10653160373032(each), 00653160373035(case), Lot Number: 2025092490;
291) ECVC5015, UDI-DI: 10653160372462(each), 00653160372465(case), Lot Number: 2025091190;
292) ECVC1045, UDI-DI: 10653160365754(each), 00653160365757(case), Lot Number: 2025091090;
293) DYNDC2681, UDI-DI: 10653160379126(each), 00653160379129(case), Lot Number: 2025091090;
294) STCVC09, UDI-DI: 10653160365273(each), 00653160365276(case), Lot Number: 2025090390;
295) ECVC6675A, UDI-DI: 10653160375951(each), 00653160375954(case), Lot Number: 2025090390;
296) ECVC5395, UDI-DI: 10653160365907(each), 00653160365900(case), Lot Number: 2025090890;
297) DYNDH1625, UDI-DI: 10653160376156(each), 00653160376159(case), Lot Number: 2025091590;
298) ECVC7000A, UDI-DI: 10653160388265(each), 00653160388268(case), Lot Number: 2025090290;
299) ECVC6395, UDI-DI: 10653160380344(each), 00653160380347(case), Lot Number: 2025090390;
300) ECVC2600, UDI-DI: 10653160363330(each), 00653160363333(case), Lot Number: 2025091090;
301) STCVC15US, UDI-DI: 10653160374749(each), 00653160374742(case), Lot Number: 2025091090;
302) ECVC6815, UDI-DI: 10653160375524(each), 00653160375527(case), Lot Number: 2025091090;
303) ECVC2940A, UDI-DI: 10653160377863(each), 00653160377866(case), Lot Number: 2025091090;
304) ECVC6540, UDI-DI: 10653160376392(each), 00653160376395(case), Lot Number: 2025091090;
305) ART685, UDI-DI: 10653160361824(each), 00653160361827(case), Lot Number: 2025090590;
306) CVI4655A, UDI-DI: 10653160364825(each), 00653160364828(case), Lot Number: 2025091090;
307) ECVC5315, UDI-DI: 10653160369110(each), 00653160369113(case), Lot Number: 2025091090;
308) 3K20N18122, UDI-DI: 10653160376330(each), 00653160376333(case), Lot Number: 2025090990;
309) ART245C, UDI-DI: 10653160373148(each), 00653160373141(case), Lot Number: 2025091090;
310) ECVC5035A, UDI-DI: 10653160389408(each), 00653160389401(case), Lot Number: 2025091090;
311) ECVC8625, UDI-DI: 10653160388098(each), 00653160388091(case), Lot Number: 2025091190;
312) ECVC2001, UDI-DI: 10653160334415(each), 00653160334418(case), Lot Number: 2025091190;
313) ART1280A, UDI-DI: 10653160373599(each), 00653160373592(case), Lot Number: 2025091290;
314) ART740, UDI-DI: 10653160366799(each), 00653160366792(case), Lot Number: 2025091290;
315) ECVC4640B, UDI-DI: 10653160388036(each), 00653160388039(case), Lot Number: 2025091190;
316) ECVC6985B, UDI-DI: 10653160388272(each), 00653160388275(case), Lot Number: 2025091290;
317) STCVC3716BPA, UDI-DI: 10653160363774(each), 00653160363777(case), Lot Number: 2025091090;
318) PICCFI6360, UDI-DI: 10653160381860(each), 00653160381863(case), Lot Number: 2025091190;
319) SUT12835, UDI-DI: 10653160365556(each), 00653160365559(case), Lot Number: 2025091290;
320) ECVC5015, UDI-DI: 10653160372462(each), 00653160372465(case), Lot Number: 2025091090;
321) ECVC5475, UDI-DI: 10653160370406(each), 00653160370409(case), Lot Number: 2025091190;
322) S7205NF85, UDI-DI: 10653160373926(each), 00653160373929(case), Lot Number: 2025091590;
323) DYNDL1605, UDI-DI: 10653160375852(each), 00653160375855(case), Lot Number: 2025090590;
324) ECVC8110, UDI-DI: 10653160377207(each), 00653160377200(case), Lot Number: 2025090290;
325) ECVC6150B, UDI-DI: 10653160388197(each), 00653160388190(case), Lot Number: 2025091090;
326) MNS6140, UDI-DI: 00653160208481(each), 10653160208488(case), Lot Number: 2025090590;
327) PT215, UDI-DI: 10653160364597(each), 00653160364590(case), Lot Number: 2025090590;
328) ECVC3285A, UDI-DI: 10653160374930(each), 00653160374933(case), Lot Number: 2025091090;
329) ECVC150A, UDI-DI: 10653160374558(each), 00653160374551(case), Lot Number: 2025090290;
330) STCVCNC01A, UDI-DI: 10653160385899(each), 00653160385892(case), Lot Number: 2025091090;
331) CHT1880B, UDI-DI: 10653160388333(each), 00653160388336(case), Lot Number: 2025090890;
332) ART240C, UDI-DI: 10653160373322(each), 00653160373325(case), Lot Number: 2025090490;
333) CMPM7163LBA, UDI-DI: 10653160376262(each), 00653160376265(case), Lot Number: 2025090990;
334) MNS11460, UDI-DI: 10653160323952(each), 00653160323955(case), Lot Number: 2025090890;
335) STCVC01, UDI-DI: 10653160364849(each), 00653160364842(case), Lot Number: 2025090290;
336) STCVC85164BPA, UDI-DI: 10653160389217(each), 00653160389210(case), Lot Number: 2025090290;
337) DYNDH1944A, UDI-DI: 10198459266799(each), 40198459266790(case), Lot Number: 25JLA661;
338) DYNJ0432367L, UDI-DI: 10195327627225(each), 40195327627226(case), Lot Number: 25ILA677;
339) PAIN9024, UDI-DI: 10889942448708(each), 40889942448709(case), Lot Number: 25JLA666;
340) TVS4500B, UDI-DI: 10195327223564(each), 40195327223565(case), Lot Number: 25JDB584;
341) TVS4500B, UDI-DI: 10195327223564(each), 40195327223565(case), Lot Number: 25KDA637 |
| 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 kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. |
|---|
FDA Determined
Cause 2 | Nonconforming Material/Component |
|---|
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 5/21/26 was sent to customers.
REQUIRED ACTION:
1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product.
2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form.
Website link: https://recalls.medline.com
Recall Reference #: R-26-082-FGX2
Recall Code:
3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.
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. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product.
If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
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| Quantity in Commerce | 48075 kits |
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| Distribution | US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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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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| 510(K) Database | 510(K)s with Product Code = LRO
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