RecallHawk
Class II Recall

Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Nu

Medline Industries, LP

Summary

The FDA issued a Class II for Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERI by Medline Industries, LP. Reason: 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 wri.

Details

Source

Device Recall

External ID

Z-3054-2026

Action Date

2026-09-09

Status

Ongoing

Category

device

Product Description

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)

Lot/Code Info: 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

Quantity Affected: 434,595 kits

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.

Distribution

US Nationwide distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-06-12

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 183 device recalls issued in the same week, part of 445 device-related FDA actions this month.

Medline Industries, LP has 577 FDA actions in our database, including 553 recalls and 24 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 577 FDA actions in our database, including 553 recalls and 24 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-3054-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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