RecallHawk
Class II Recall

Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH CENTRAL LINE KIT, Model Numbe

Medline Industries, LP

Summary

The FDA issued a Class II for Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; by Medline Industries, LP. Reason: 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. f.

Details

Source

Device Recall

External ID

Z-2541-2026

Action Date

2026-07-08

Status

Ongoing

Category

device

Product Description

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

Lot/Code Info: 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

Quantity Affected: 48075 kits

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.

Distribution

US Nationwide distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-05-21

Company

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 186 device recalls issued in the same week, part of 534 device-related FDA actions this month.

Medline Industries, LP has 487 FDA actions in our database, including 459 recalls and 28 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Medline Industries, LP have FDA actions?

Medline Industries, LP has 487 FDA actions in our database, including 459 recalls and 28 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2541-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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