FDAFDA recall Z-3054-2026 · Sep 9, 2026

Medline Industries, LP: Medline Convenience Kits: 1) IV START KIT recall

Recall found

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)

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.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status: Ongoing
Codes, lots and dates: 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: 434,595 kits
Distribution: US Nationwide distribution.
Recalling firm: Medline Industries, LP, Northfield, IL
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-06-12

Source: openFDA enforcement record Z-3054-2026 · search recall number Z-3054-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.