Class 2 Device Recall Medline Convenience Kits

• Date Initiated by Firm: June 12, 2026
• Date Posted: August 31, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3054-2026
• Recall Event ID: 99334
• 510(K)Number: K213481
• Product Classification: General surgery tray - Product Code LRO
• Product: Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY TRAY-PURPLE, Catalog Number: ACC010157C; 4) PEDS EMERGENCY TRAY- GREEN, Catalog Number: ACC010158C; 5) PEDI EMERGENCY TRAY-BLUE, Catalog Number: ACC010159C; 6) PEDS EMERGENCY TRAY-YELLOW, Catalog Number: ACC010160C; 7) PEDS EMERGENCY TRAY-WHITE, Catalog Number: ACC010161C; 8) PEDS EMERGENCY TRAY-ORANGE, Catalog Number: ACC010162C; 9) PEDS EMERGENCY TRAY-RED, Catalog Number: ACC010163C; 10) CVHP DRAWER -IV, Catalog Number: ACC010308A; 11) PEDI EMERGENCY TRAY-BLUE, Catalog Number: ACC010316A; 12) PEDS EMERGENCY TRAY- GREEN, Catalog Number: ACC010318A; 13) PEDS EMERGENCY TRAY-ORANGE, Catalog Number: ACC010319A; 14) DRAWER THREE - IV SET UP, Catalog Number: ACC010361; 15) DRAWER 1, Catalog Number: ACC010374A; 16) DRAWER 3 LAB DRAW & IV START, Catalog Number: ACC010417A; 17) DRAWER #6, Catalog Number: ACC010477B; 18) DRAWER #4, Catalog Number: ACC010479A; 19) ADULT DRAWER 4, Catalog Number: ACC010679; 20) DRAWER 2, Catalog Number: ACC010690; 21) DRAWER 2, Catalog Number: ACC010726; 22) DRAWER 2, Catalog Number: ACC010726A; 23) RRMC CODE CART DRAWER 3, Catalog Number: ACC010770; 24) DRAWER 2, Catalog Number: ACC010875; 25) BOTTOM DRAWER, Catalog Number: ACC010972; 26) CODE CART DRAWER TWO IV SUPPLI, Catalog Number: ACC010977; 27) DRAWER 4 CIRCULATION, Catalog Number: ACC011088; 28) NON-SUTURED SHEATH #113197 KIT, Catalog Number: DYKM1495; 29) SUTURED SHEATH W/SCI #113198, Catalog Number: DYKM1496; 30) LABOR TRIAGE KIT - LF #13232, Catalog Number: DYKM1564; 31) FINGER THORACOSTOMY PCC KIT, Catalog Number: DYKM2676A; 32) UVC KIT, Catalog Number: DYKM2677A; 33) CRIC KIT, Catalog Number: DYKM2678A; 34) SCOPE KIT 3, Catalog Number: DYKM2750; 35) SURGICAL KIT, Catalog Number: DYKM2752; 36) PRE OP KIT, Catalog Number: DYKS1022B; 37) MAC KIT, Catalog Number: DYKS1089B; 38) PRE OP KIT, Catalog Number: DYKS1091A; 39) PRE OP KIT, Catalog Number: DYKS1128B; 40) PRE OP KIT, Catalog Number: DYKS1325; 41) UCLA RAPID RESPONSE KIT, Catalog Number: DYLAB1097; 42) BSSM-WHOLE BLOOD PHLEBOTOMY, Catalog Number: DYNDB3061; 43) WHOLE BLOOD PHLEBOTOMY, Catalog Number: DYNDB3064; 44) WHOLE BLOOD/DOUBLE RED, Catalog Number: DYNDB3078C; 45) ACCESS KIT, Catalog Number: DYNDH1159A; 46) ADLT BLOOD CULTURE COLLECT KIT, Catalog Number: DYNDH1245; 47) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1362; 48) PEDIATRIC BLOOD CULTURE KIT, Catalog Number: DYNDH1363; 49) STANFORD TIME TO POSITIVITY, Catalog Number: DYNDH1591; 50) BLOOD CULTURE PINK PERIPHERAL, Catalog Number: DYNDV1875; 51) BLOOD CULTURE BLUE PERIPHERAL, Catalog Number: DYNDV1876; 52) NICU LINE PACK, Catalog Number: DYNJ63410; 53) STUDENT PRACTICE BAG W LOGO, Catalog Number: EDUC1043; 53)
• Code Information: 1) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2023122690; 2) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024020790; 3) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024032790; 4) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024052390; 5) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024071190; 6) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024081490; 7) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024101090; 8) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024111990; 9) DYNDH1983A, UDI-DI: 10653160388920(each), 00653160388923(case), Lot Number: 2025073190; 10) ACC010157C, UDI-DI: 10195327492649(each), 40195327492640(case), Lot Number: 23JDB105; 11) ACC010158C, UDI-DI: 10195327492786(each), 40195327492787(case), Lot Number: 23JDB122; 12) ACC010159C, UDI-DI: 10195327492779(each), 40195327492770(case), Lot Number: 23JDB078; 13) ACC010160C, UDI-DI: 10195327492823(each), 40195327492824(case), Lot Number: 23JDA433; 14) ACC010160C, UDI-DI: 10195327492823(each), 40195327492824(case), Lot Number: 23JDB266; 15) ACC010161C, UDI-DI: 10195327492816(each), 40195327492817(case), Lot Number: 23JDA587; 16) ACC010161C, UDI-DI: 10195327492816(each), 40195327492817(case), Lot Number: 23JDB267; 17) ACC010161C, UDI-DI: 10195327492816(each), 40195327492817(case), Lot Number: 23JDC145; 18) ACC010162C, UDI-DI: 10195327492793(each), 40195327492794(case), Lot Number: 23JDB106; 19) ACC010163C, UDI-DI: 10195327492809(each), 40195327492800(case), Lot Number: 23JDB268; 20) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25DDA404; 21) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25EDB078; 22) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25FDA297; 23) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25FDB295; 24) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25GDA555; 25) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 24FDB461; 26) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 24FDB645; 27) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 23KDC062; 28) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 23LDB762; 29) ACC010316A, UDI-DI: 10889942831746(each), 40889942831747(case), Lot Number: 25CDB196; 30) ACC010316A, UDI-DI: 10889942831746(each), 40889942831747(case), Lot Number: 24DDA506; 31) ACC010316A, UDI-DI: 10889942831746(each), 40889942831747(case), Lot Number: 24EDA984; 32) ACC010316A, UDI-DI: 10889942831746(each), 40889942831747(case), Lot Number: 24LDA823; 33) ACC010318A, UDI-DI: 10889942831760(each), 40889942831761(case), Lot Number: 24EDC133; 34) ACC010318A, UDI-DI: 10889942831760(each), 40889942831761(case), Lot Number: 23KDA881; 35) ACC010319A, UDI-DI: 10889942831777(each), 40889942831778(case), Lot Number: 24DDA262; 36) ACC010319A, UDI-DI: 10889942831777(each), 40889942831778(case), Lot Number: 24DDA507; 37) ACC010319A, UDI-DI: 10889942831777(each), 40889942831778(case), Lot Number: 24EDB665; 38) ACC010319A, UDI-DI: 10889942831777(each), 40889942831778(case), Lot Number: 23JDB228; 39) ACC010361, UDI-DI: 10889942944989(each), 40889942944980(case), Lot Number: 24ADA597; 40) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 25CDB687; 41) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 25EDB273; 42) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 25FDA380; 43) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24ADA326; 44) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24DDC115; 45) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24EDB585; 46) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24FDA451; 47) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24JDA313; 48) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24LDA107; 49) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 23KDB464; 50) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 23KDC441; 51) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 23LDB221; 52) ACC010417A, UDI-DI: 10195327230043(each), 40195327230044(case), Lot Number: 25BDA421; 53) ACC010417A, UDI-DI: 10195327230043(each), 40195327230044(case), Lot Number: 25FDB683; 54) ACC010417A, UDI-DI: 10195327230043(each), 40195327230044(case), Lot Number: 24JDA799; 55) ACC010417A, UDI-DI: 10195327230043(each), 40195327230044(case), Lot Number: 24KDB853; 56) ACC010417A, UDI-DI: 10195327230043(each), 40195327230044(case), Lot Number: 23JDB187; 57) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 25CDA651; 58) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 25EDB703; 59) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 25GDB405; 60) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 24ADB209; 61) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 24BDA093; 62) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 24BDA446; 63) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 24BDC015; 64) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 24CDB041; 65) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 24DDB732; 66) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 24EDA124; 67) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 24KDA544; 68) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 23LDA976; 69) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 25DDA606; 70) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 25EDB678; 71) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 25FDA196; 72) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 25HDA602; 73) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 24DDB117; 74) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 24EDA750; 75) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 24FDB890; 76) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 24HDA095; 77) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 24IDA021; 78) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 23KDB046; 79) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 23KDC470; 80) ACC010479A, UDI-DI: 23LDB379(each), 10195327131517(case), Lot Number: 40195327131518; 81) ACC010679, UDI-DI: 25ADB289(each), 10195327396268(case), Lot Number: 40195327396269; 82) ACC010679, UDI-DI: 10195327396268(each), 40195327396269(case), Lot Number: 25CDA527; 83) ACC010679, UDI-DI: 10195327396268(each), 40195327396269(case), Lot Number: 25EDC013; 84) ACC010679, UDI-DI: 10195327396268(each), 40195327396269(case), Lot Number: 24ADA519; 85) ACC010679, UDI-DI: 10195327396268(each), 40195327396269(case), Lot Number: 24ADC040; 86) ACC010679, UDI-DI: 10195327396268(each), 40195327396269(case), Lot Number: 24JDA657; 87) ACC010679, UDI-DI: 10195327396268(each), 40195327396269(case), Lot Number: 24LDB799; 88) ACC010679, UDI-DI: 10195327396268(each), 40195327396269(case), Lot Number: 23GDB618; 89) ACC010690, UDI-DI: 10195327433307(each), 40195327433308(case), Lot Number: 25GDA245; 90) ACC010690, UDI-DI: 10195327433307(each), 40195327433308(case), Lot Number: 24CDB296; 91) ACC010690, UDI-DI: 10195327433307(each), 40195327433308(case), Lot Number: 24DDB313; 92) ACC010690, UDI-DI: 10195327433307(each), 40195327433308(case), Lot Number: 24EDA327; 93) ACC010690, UDI-DI: 10195327433307(each), 40195327433308(case), Lot Number: 24GDB902; 94) ACC010690, UDI-DI: 10195327433307(each), 40195327433308(case), Lot Number: 24JDA372; 95) ACC010726, UDI-DI: 10195327486402(each), 40195327486403(case), Lot Number: 24ADA800; 96) ACC010726, UDI-DI: 10195327486402(each), 40195327486403(case), Lot Number: 24BDB414; 97) ACC010726, UDI-DI: 10195327486402(each), 40195327486403(case), Lot Number: 23JDA881; 98) ACC010726A, UDI-DI: 10198459043666(each), 40198459043667(case), Lot Number: 24GDA002; 99) ACC010770, UDI-DI: 10195327576998(each), 40195327576999(case), Lot Number: 24ADB026; 100) ACC010770, UDI-DI: 10195327576998(each), 40195327576999(case), Lot Number: 24ADB445; 101) ACC010770, UDI-DI: 10195327576998(each), 40195327576999(case), Lot Number: 24ADB860; 102) ACC010770, UDI-DI: 10195327576998(each), 40195327576999(case), Lot Number: 24ADC225; 103) ACC010770, UDI-DI: 10195327576998(each), 40195327576999(case), Lot Number: 24BDB043; 104) ACC010770, UDI-DI: 10195327576998(each), 40195327576999(case), Lot Number: 24CDA646; 105) ACC010770, UDI-DI: 10195327576998(each), 40195327576999(case), Lot Number: 24CDC111; 106) ACC010875, UDI-DI: 10198459113659(each), 40198459113650(case), Lot Number: 25DDB627; 107) ACC010875, UDI-DI: 10198459113659(each), 40198459113650(case), Lot Number: 24JDA648; 108) ACC010972, UDI-DI: 10198459303289(each), 40198459303280(case), Lot Number: 25EDA655; 109) ACC010977, UDI-DI: 10198459308642(each), 40198459308643(case), Lot Number: 25DDA901; 110) ACC011088, UDI-DI: 10198459589577(each), 40198459589578(case), Lot Number: 26BDA548; 111) DYKM1495, UDI-DI: 10889942639748(each), 40889942639749(case), Lot Number: 23KBE256; 112) DYKM1496, UDI-DI: 10889942636082(each), 40889942636083(case), Lot Number: 24DBH449; 113) DYKM1496, UDI-DI: 10889942636082(each), 40889942636083(case), Lot Number: 24JBB668; 114) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 25DBK369; 115) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 25GBH209; 116) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 24LBR594; 117) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 24ABG494; 118) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 24CBB243; 119) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 24CBD763; 120) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 24DBI378; 121) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 24EBR566; 122) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 24GBX258; 123) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 24JBX634; 124) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 23IBF967; 125) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 23LBI141; 126) DYKM2676A, UDI-DI: 10195327522988(each), 40195327522989(case), Lot Number: 25BBE461; 127) DYKM2676A, UDI-DI: 10195327522988(each), 40195327522989(case), Lot Number: 24CBH132; 128) DYKM2676A, UDI-DI: 10195327522988(each), 40195327522989(case), Lot Number: 24CBT727; 129) DYKM2676A, UDI-DI: 10195327522988(each), 40195327522989(case), Lot Number: 23LBN569; 130) DYKM2677A, UDI-DI: 10195327522995(each), 40195327522996(case), Lot Number: 23LBU445; 131) DYKM2677A, UDI-DI: 10195327522995(each), 40195327522996(case), Lot Number: 24CBP143; 132) DYKM2677A, UDI-DI: 10195327522995(each), 40195327522996(case), Lot Number: 24DBF109; 133) DYKM2677A, UDI-DI: 10195327522995(each), 40195327522996(case), Lot Number: 23JBP672; 134) DYKM2678A, UDI-DI: 10195327523008(each), 40195327523009(case), Lot Number: 25BLA823; 135) DYKM2678A, UDI-DI: 10195327523008(each), 40195327523009(case), Lot Number: 25DLA868; 136) DYKM2678A, UDI-DI: 10195327523008(each), 40195327523009(case), Lot Number: 24CLA476; 137) DYKM2678A, UDI-DI: 10195327523008(each), 40195327523009(case), Lot Number: 24LLA140; 138) DYKM2678A, UDI-DI: 10195327523008(each), 40195327523009(case), Lot Number: 23LLA884; 139) DYKM2750, UDI-DI: 10198459112690(each), 40198459112691(case), Lot Number: 24JBB774; 140) DYKM2752, UDI-DI: 10198459118401(each), 40198459118402(case), Lot Number: 24KBK304; 141) DYKM2752, UDI-DI: 10198459118401(each), 40198459118402(case), Lot Number: 24KBG695; 142) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 25AMF164; 143) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24AMA227; 144) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24AMA782; 145) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24AMH643; 146) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24CMD293; 147) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24DMF883; 148) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24EMJ967; 149) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24GMH029; 150) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24GMK146; 151) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24JMH465; 152) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24KMJ204; 153) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24LME558; 154) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 23JMJ533; 155) DYKS1089B, UDI-DI: 10193489306286(each), 40193489306287(case), Lot Number: 25CMA215; 156) DYKS1089B, UDI-DI: 10193489306286(each), 40193489306287(case), Lot Number: 24BMB722; 157) DYKS1089B, UDI-DI: 10193489306286(each), 40193489306287(case), Lot Number: 24DMA601; 158) DYKS1089B, UDI-DI: 10193489306286(each), 40193489306287(case), Lot Number: 24EMB032; 159) DYKS1089B, UDI-DI: 10193489306286(each), 40193489306287(case), Lot Number: 24GMH030; 160) DYKS1089B, UDI-DI: 10193489306286(each), 40193489306287(case), Lot Number: 24GMK147; 161) DYKS1089B, UDI-DI: 10193489306286(each), 40193489306287(case), Lot Number: 24HMI067; 162) DYKS1089B, UDI-DI: 10193489306286(each), 40193489306287(case), Lot Number: 24LMD918; 163) DYKS1089B, UDI-DI: 10193489306286(each), 40193489306287(case), Lot Number: 23KMF447; 164) DYKS1091A, UDI-DI: 10193489574319(each), 40193489574310(case), Lot Number: 25AMG863; 165) DYKS1091A, UDI-DI: 10193489574319(each), 40193489574310(case), Lot Number: 25BMC075; 166) DYKS1091A, UDI-DI: 10193489574319(each), 40193489574310(case), Lot Number: 23LMH153; 167) DYKS1091A, UDI-DI: 10193489574319(each), 40193489574310(case), Lot Number: 24EMF530; 168) DYKS1091A, UDI-DI: 10193489574319(each), 40193489574310(case), Lot Number: 24IMC383; 169) DYKS1091A, UDI-DI: 10193489574319(each), 40193489574310(case), Lot Number: 24LMF652; 170) DYKS1091A, UDI-DI: 10193489574319(each), 40193489574310(case), Lot Number: 23JMG324; 171) DYKS1128B, UDI-DI: 10193489983043(each), 40193489983044(case), Lot Number: 23LBU122; 172) DYKS1128B, UDI-DI: 10193489983043(each), 40193489983044(case), Lot Number: 23LBH912; 173) DYKS1325, UDI-DI: 10193489983036(each), 40193489983037(case), Lot Number: 23JBP437; 174) DYKS1325, UDI-DI: 10193489983036(each), 40193489983037(case), Lot Number: 23KBL343; 175) DYKS1325, UDI-DI: 10193489983036(each), 40193489983037(case), Lot Number: 23LBH895; 176) DYKS1325, UDI-DI: 10193489983036(each), 40193489983037(case), Lot Number: 23LBP617; 177) DYLAB1097, UDI-DI: 10198459346316(each), 40198459346317(case), Lot Number: 25FLA513; 178) DYLAB1097, UDI-DI: 10198459346316(each), 40198459346317(case), Lot Number: 25GLA297; 179) DYLAB1097, UDI-DI: 10198459346316(each), 40198459346317(case), Lot Number: 25HLA636; 180) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 25CBJ821; 181) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 24ABY315; 182) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 24CBK867; 183) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 24DBL293; 184) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 24FBA828; 185) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 24JBI833; 186) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 24JBX194; 187) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 23KBJ574; 188) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 23KBV200; 189) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 23LBI823; 190) DYNDB3064, UDI-DI: 10889942215782(each), 40889942215783(case), Lot Number: 25ABB074; 191) DYNDB3064, UDI-DI: 10889942215782(each), 40889942215783(case), Lot Number: 25BBP541; 192) DYNDB3064, UDI-DI: 10889942215782(each), 40889942215783(case), Lot Number: 24ABW521; 193) DYNDB3064, UDI-DI: 10889942215782(each), 40889942215783(case), Lot Number: 24CBA610; 194) DYNDB3064, UDI-DI: 10889942215782(each), 40889942215783(case), Lot Number: 24DBE339; 195) DYNDB3064, UDI-DI: 10889942215782(each), 40889942215783(case), Lot Number: 24FBC085; 196) DYNDB3064, UDI-DI: 10889942215782(each), 40889942215783(case), Lot Number: 24IBR193; 197) DYNDB3064, UDI-DI: 10889942215782(each), 40889942215783(case), Lot Number: 24JBQ751; 198) DYNDB3064, UDI-DI: 10889942215782(each), 40889942215783(case), Lot Number: 23KBQ427; 199) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 25ABE987; 200) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 25BBI439; 201) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 25CBN467; 202) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24KBJ660; 203) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24LBE165; 204) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24ABE056; 205) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24ABG510; 206) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24CBG613; 207) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24CBT164; 208) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24EBR367; 209) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24FBJ717; 210) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24HBG037; 211) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24JBB679; 212) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 23IBS706; 213) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 23JBP441; 214) DYNDH1159A, UDI-DI: 10889942881659(each), 40889942881650(case), Lot Number: 24BBR188; 215) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 25KME694; 216) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 25AMD339; 217) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 25AMI448; 218) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 25BMB198; 219) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 25BMD503; 220) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 25BMH151; 221) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 23LMH919; 222) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24AMF220; 223) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24AMJ457; 224) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24BMB874; 225) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24BMI381; 226) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24CMC934; 227) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24CMG933; 228) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24CMK091; 229) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24DMF489; 230) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24EMA066; 231) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24EMH953; 232) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24GMB441; 233) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24GMF372; 234) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24GMG553; 235) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24GMI902; 236) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24IMD769; 237) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24JMI883; 238) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 23JMC106; 239) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 23JME609; 240) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 23JMJ056; 241) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 23KMA305; 242) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 23KMJ911; 243) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24CMK091Z; 244) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 25ABC490; 245) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 25ABT234; 246) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 25BBB152; 247) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24LBD414; 248) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24LBN281; 249) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24ABI528; 250) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24ABS533; 251) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24BBJ514; 252) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24CBA543; 253) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24CBK879; 254) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24CBQ864; 255) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24DBE149; 256) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24DBR058; 257) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24FBD953; 258) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24GBO300; 259) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24IBL629; 260) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24JBE586; 261) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24JBQ159; 262) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24KBE076; 263) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 23JBW105; 264) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 23LBE015; 265) DYNDH1363, UDI-DI: 10888277795464(each), 40888277795465(case), Lot Number: 25DBH954; 266) DYNDH1363, UDI-DI: 10888277795464(each), 40888277795465(case), Lot Number: 25GBD824; 267) DYNDH1363, UDI-DI: 10888277795464(each), 40888277795465(case), Lot Number: 23LBQ779; 268) DYNDH1363, UDI-DI: 10888277795464(each), 40888277795465(case), Lot Number: 24ABY394; 269) DYNDH1363, UDI-DI: 10888277795464(each), 40888277795465(case), Lot Number: 24CBF326; 270) DYNDH1363, UDI-DI: 10888277795464(each), 40888277795465(case), Lot Number: 24DBL545; 271) DYNDH1363, UDI-DI: 10888277795464(each), 40888277795465(case), Lot Number: 24EBI891; 272) DYNDH1363, UDI-DI: 10888277795464(each), 40888277795465(case), Lot Number: 24FBN485; 273) DYNDH1363, UDI-DI: 10888277795464(each), 40888277795465(case), Lot Number: 23KBA941; 274) DYNDH1591, UDI-DI: 10193489497236(each), 40193489497237(case), Lot Number: 23LMH149; 275) DYNDH1591, UDI-DI: 10193489497236(each), 40193489497237(case), Lot Number: 24BMF431; 276) DYNDH1591, UDI-DI: 10193489497236(each), 40193489497237(case), Lot Number: 24GMF832; 277) DYNDH1591, UDI-DI: 10193489497236(each), 40193489497237(case), Lot Number: 24IME659; 278) DYNDH1591, UDI-DI: 10193489497236(each), 40193489497237(case), Lot Number: 24IMI021; 279) DYNDH1591, UDI-DI: 10193489497236(each), 40193489497237(case), Lot Number: 24JMA966; 280) DYNDV1875, UDI-DI: 10888277860209(each), 40888277860200(case), Lot Number: 24AME774; 281) DYNDV1876, UDI-DI: 10888277860032(each), 40888277860033(case), Lot Number: 24CMG621; 282) DYNDV1876, UDI-DI: 10888277860032(each), 40888277860033(case), Lot Number: 24CMH613; 283) DYNDV1876, UDI-DI: 10888277860032(each), 40888277860033(case), Lot Number: 24DMH848; 284) DYNJ63410, UDI-DI: 10193489737431(each), 40193489737432(case), Lot Number: 25CDA509; 285) DYNJ63410, UDI-DI: 10193489737431(each), 40193489737432(case), Lot Number: 25CDA643; 286) DYNJ63410, UDI-DI: 10193489737431(each), 40193489737432(case), Lot Number: 25CDB663; 287) DYNJ63410, UDI-DI: 10193489737431(each), 40193489737432(case), Lot Number: 24ADB665; 288) DYNJ63410, UDI-DI: 10193489737431(each), 40193489737432(case), Lot Number: 24IDB069; 289) DYNJ63410, UDI-DI: 10193489737431(each), 40193489737432(case), Lot Number: 24IDB669; 290) DYNJ63410, UDI-DI: 10193489737431(each), 40193489737432(case), Lot Number: 23LDA067; 291) DYNJ63410, UDI-DI: 10193489737431(each), 40193489737432(case), Lot Number: 23LDA811; 292) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 24ADA018; 293) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 24DDB177; 294) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 24DDB234; 295) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 24GDB033; 296) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 24HDA202; 297) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 24HDA894; 298) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 24HDB180; 299) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 23LDA532; 300) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 23LDB267; 301) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 23LDB288; 302) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 23LDB289; 303) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 23LDB290; 304) EDUC1043A, UDI-DI: 10198459334559(each), 40198459334550(case), Lot Number: 25ELA281
• 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 contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.
• FDA Determined Cause: Nonconforming Material/Component
• Action: An URGENT MEDICAL DEVICE RECALL notification letter dated 6/12/25 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-26-097-FGX1 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.
• Quantity in Commerce: 434,595 kits
• 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.

• 510(K) Database: 510(K)s with Product Code = LRO