Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2) WHOLE BLOOD PHLEBOTOMY KIT, Catalog Number... — FDA record Z-3063-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 12, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2) WHOLE BLOOD PHLEBOTOMY KIT, Catalog Number: DYNDB3005D; 3) QP KIT, Catalog Number: DYNDB3005F; 4) DOUBLE RED CELL PHLEBOTOMY KIT, Catalog Number: DYNDB3006C; 5) PLATELET PHLEBOTOMY KIT, Catalog Number: DYNDB3007C; 6) WHOLE BLOOD KIT, Catalog Number: DYNDB3041D; 7) PHLEBOTOMY, Catalog Number: DYNDB3044D; 8) PHLEBOTOMY, Catalog Number: DYNDB3044F; 9) DONATION - WB, Catalog Number: DYNDB3086D; 10) DONATION - ALYX/TRIMA W/O TOUR, Catalog Number: DYNDB3088B; 11) THERAPEUTIC NFT, Catalog Number: DYNDB3100; 12) BLOOD CULTURE TRAY ADULT, Catalog Number: DYNDH1194A; 13) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1444D; 14) PEDS BLOOD CULTURE KIT, Catalog Number: DYNDH1445C; 15) BLOOD CULTURE KIT, Catalog Number: DYNDH1462B; 16) BLOOD CULTURE ADULT, Catalog Number: DYNDH1619A; 17) BLOOD CULTURE PEDI, Catalog Number: DYNDH1620A; 18) BLOOD CULTURE KIT, Catalog Number: DYNDH1622C; 19) BLOOD CULTURE KIT, Catalog Number: DYNDH1622D; 20) BLOOD CULTURE COLLECTION KIT, Catalog Number: DYNDH1626B; 21) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1694A; 22) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1695; 23) BLOOD CULTURE KIT, Catalog Number: DYNDH1708A; 24) BLOOD CULTURE COLLECTION KIT, Catalog Number: DYNDH1714A; 25) BLOOD CULTURE KIT, Catalog Number: DYNDH1715B; 26) BLOOD CULTURE KIT, Catalog Number: DYNDH1723; 27) NS BLOOD CULTURE 23G KIT, Catalog Number: DYNDH1740A; 28) NS BLOOD CULTURE 23G KIT, Catalog Number: DYNDH1740B; 29) NS BLOOD CULTURE 21G KIT, Catalog Number: DYNDH1741A; 30) NS BLOOD CULTURE 21G KIT, Catalog Number: DYNDH1741B; 31) PEDS BLOOD CULTURE KIT, Catalog Number: DYNDH1771A; 32) BLOOD CULTURE KIT, Catalog Number: DYNDH1805B; 33) BLOOD CULTURE KIT, Catalog Number: DYNDH1817A; 34) BLOOD CULTR KT DIVRSN DEVICE, Catalog Number: DYNDH1866; 35) BLOOD CULTURE KIT, Catalog Number: DYNDH1867; 36) BLOOD CULTURE KIT, Catalog Number: DYNDH1884; 37) PHLEBOTOMY BLOOD CULTURE KIT, Catalog Number: DYNDH1908; 38) BLOOD CULTURE KIT, Catalog Number: DYNDH1912; 39) BLOOD CULTURE KIT, Catalog Number: DYNDH1940; 40) BLOOD CULTURE KIT W/O BOTTLES, Catalog Number: DYNDH1985; 41) BLOOD CULTURE KIT, Catalog Number: DYNDH1988; 42) BLOOD CULTURE, Catalog Number: DYNDH2002; 43) BLOOD CULTURE W/NO IV, Catalog Number: DYNDH2016; 44) BLOOD CULTURE W/IV, Catalog Number: DYNDH2017; 45) BLOOD CULTURE KIT, Catalog Number: DYNDH2023; 46) BLOOD CULTURE KIT, Catalog Number: DYNDH2028; 47) BLOOD CULTURE KIT, Catalog Number: DYNDH2030; 48) BLOOD CULTURE KIT, Catalog Number: DYNDH2048; 49) BLOOD CULTURE KIT, Catalog Number: DYNDH2059; 50) BLOOD CULTURE KIT 450, Catalog Number: DYNDH2074; 51) BLOOD CULTURE-NB, Catalog Number: DYNDH2089
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 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.
Classification
Class II
Recalling firm
Medline Industries, LP
Quantity
996692 kits
Agency-reported status
Ongoing
Source record identifier
Z-3063-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicability1) DYLAB1081, UDI-DI: 10198459199608(each), 40198459199609(case), Lot Number: 25CMC514; 2) DYNDB3005D, UDI-DI: 10195327038700(each), 40195327038701(case), Lot Number: 24CBG614; 3) DYNDB3005D, UDI-DI: 10195327038700(each), 40195327038701(case), Lot Number: 24CBT912; 4) DYNDB3005D, UDI-DI: 10195327038700(each), 40195327038701(case), Lot Number: 23HBH298; 5) DYNDB3005D, UDI-DI: 10195327038700(each), 40195327038701(case), Lot Number: 23JBN521; 6) DYNDB3005D, UDI-DI: 10195327038700(each), 40195327038701(case), Lot Number: 23KBT270; 7) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 25BBD241; 8) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 25BBP477; 9) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 25CBI161; 10) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 24LBM458; 11) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 24FBL961; 12) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 24FBS200; 13) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 24IBO183; 14) DYNDB3006C, UDI-DI: 10195327038717(each), 40195327038718(case), Lot Number: 24ABB637; 15) DYNDB3006C, UDI-DI: 10195327038717(each), 40195327038718(case), Lot Number: 24ABY532; 16) DYNDB3006C, UDI-DI: 10195327038717(each), 40195327038718(case), Lot Number: 24CBH932; 17) DYNDB3006C, UDI-DI: 10195327038717(each), 40195327038718(case), Lot Number: 23JBN434; 18) DYNDB3006C, UDI-DI: 10195327038717(each), 40195327038718(case), Lot Number: 23LBH909; 19) DYNDB3007C, UDI-DI: 10195327038724(each), 40195327038725(case), Lot Number: 24CBL044; 20) DYNDB3007C, UDI-DI: 10195327038724(each), 40195327038725(case), Lot Number: 23JBC957; 21) DYNDB3007C, UDI-DI: 10195327038724(each), 40195327038725(case), Lot Number: 23KBT835; 22) DYNDB3007C, UDI-DI: 10195327038724(each), 40195327038725(case), Lot Number: 23LBI822; 23) DYNDB3041D, UDI-DI: 10195327170738(each), 40195327170739(case), Lot Number: 24KBS893; 24) DYNDB3044D, UDI-DI: 10195327028565(each), 40195327028566(case), Lot Number: 24ABH596; 25) DYNDB3044D, UDI-DI: 10195327028565(each), 40195327028566(case), Lot Number: 23KBB360; 26) DYNDB3044D, UDI-DI: 10195327028565(each), 40195327028566(case), Lot Number: 23LBI693; 27) DYNDB3044F, UDI-DI: 10195327661236(each), 40195327661237(case), Lot Number: 25BBA987; 28) DYNDB3044F, UDI-DI: 10195327661236(each), 40195327661237(case), Lot Number: 24LBE163; 29) DYNDB3044F, UDI-DI: 10195327661236(each), 40195327661237(case), Lot Number: 24DBO764; 30) DYNDB3044F, UDI-DI: 10195327661236(each), 40195327661237(case), Lot Number: 24DBO786; 31) DYNDB3044F, UDI-DI: 10195327661236(each), 40195327661237(case), Lot Number: 24EBD140; 32) DYNDB3044F, UDI-DI: 10195327661236(each), 40195327661237(case), Lot Number: 24GBR601; 33) DYNDB3044F, UDI-DI: 10195327661236(each), 40195327661237(case), Lot Number: 24IBR933; 34) DYNDB3086D, UDI-DI: 10195327313234(each), 40195327313235(case), Lot Number: 24LBR503; 35) DYNDB3086D, UDI-DI: 10195327313234(each), 40195327313235(case), Lot Number: 23LBM024; 36) DYNDB3086D, UDI-DI: 10195327313234(each), 40195327313235(case), Lot Number: 24BBM148; 37) DYNDB3086D, UDI-DI: 10195327313234(each), 40195327313235(case), Lot Number: 24CBN122; 38) DYNDB3086D, UDI-DI: 10195327313234(each), 40195327313235(case), Lot Number: 24FBC084; 39) DYNDB3086D, UDI-DI: 10195327313234(each), 40195327313235(case), Lot Number: 24JBV595; 40) DYNDB3086D, UDI-DI: 10195327313234(each), 40195327313235(case), Lot Number: 23JBL111; 41) DYNDB3088B, UDI-DI: 10195327086275(each), 40195327086276(case), Lot Number: 25ABB075; 42) DYNDB3088B, UDI-DI: 10195327086275(each), 40195327086276(case), Lot Number: 24BBO180; 43) DYNDB3088B, UDI-DI: 10195327086275(each), 40195327086276(case), Lot Number: 24CBN068; 44) DYNDB3088B, UDI-DI: 10195327086275(each), 40195327086276(case), Lot Number: 24DBW006; 45) DYNDB3088B, UDI-DI: 10195327086275(each), 40195327086276(case), Lot Number: 24IBC763; 46) DYNDB3088B, UDI-DI: 10195327086275(each), 40195327086276(case), Lot Number: 24JBA762; 47) DYNDB3088B, UDI-DI: 10195327086275(each), 40195327086276(case), Lot Number: 24JBX189; 48) DYNDB3088B, UDI-DI: 10195327086275(each), 40195327086276(case), Lot Number: 23JBY503; 49) DYNDB3088B, UDI-DI: 10195327086275(each), 40195327086276(case), Lot Number: 23LBM098; 50) DYNDB3100, UDI-DI: 10198459028915(each), 40198459028916(case), Lot Number: 24GBF854; 51) DYNDH1194A, UDI-DI: 10195327432300(each), 40195327432301(case), Lot Number: 23KBQ229; 52) DYNDH1444D, UDI-DI: 10195327502492(each), 40195327502493(case), Lot Number: 25ABW691; 53) DYNDH1444D, UDI-DI: 10195327502492(each), 40195327502493(case), Lot Number: 25DBO475; 54) DYNDH1444D, UDI-DI: 10195327502492(each), 40195327502493(case), Lot Number: 25EBD598; 55) DYNDH1444D, UDI-DI: 10195327502492(each), 40195327502493(case), Lot Number: 25FBQ279; 56) DYNDH1444D, UDI-DI: 10195327502492(each), 40195327502493(case), Lot Number: 23LBU409; 57) DYNDH1444D, UDI-DI: 10195327502492(each), 40195327502493(case), Lot Number: 24CBQ394; 58) DYNDH1444D, UDI-DI: 10195327502492(each), 40195327502493(case), Lot Number: 24EBI903; 59) DYNDH1444D, UDI-DI: 10195327502492(each), 40195327502493(case), Lot Number: 24GBH145; 60) DYNDH1444D, UDI-DI: 10195327502492(each), 40195327502493(case), Lot Number: 23JBI911; 61) DYNDH1444D, UDI-DI: 10195327502492(each), 40195327502493(case), Lot Number: 23JBQ284; 62) DYNDH1445C, UDI-DI: 10195327502614(each), 40195327502615(case), Lot Number: 24LBU139; 63) DYNDH1445C, UDI-DI: 10195327502614(each), 40195327502615(case), Lot Number: 25BBE915; 64) DYNDH1445C, UDI-DI: 10195327502614(each), 40195327502615(case), Lot Number: 25EBD601; 65) DYNDH1445C, UDI-DI: 10195327502614(each), 40195327502615(case), Lot Number: 24ABT708; 66) DYNDH1445C, UDI-DI: 10195327502614(each), 40195327502615(case), Lot Number: 24CBH112; 67) DYNDH1445C, UDI-DI: 10195327502614(each), 40195327502615(case), Lot Number: 24DBS252; 68) DYNDH1445C, UDI-DI: 10195327502614(each), 40195327502615(case), Lot Number: 24FBH711; 69) DYNDH1445C, UDI-DI: 10195327502614(each), 40195327502615(case), Lot Number: 23KBH644; 70) DYNDH1445C, UDI-DI: 10195327502614(each), 40195327502615(case), Lot Number: 23KBV432; 71) DYNDH1445C, UDI-DI: 10195327502614(each), 40195327502615(case), Lot Number: 23LBJ808; 72) DYNDH1462B, UDI-DI: 10195327662462(each), 40195327662463(case), Lot Number: 25ABK267; 73) DYNDH1462B, UDI-DI: 10195327662462(each), 40195327662463(case), Lot Number: 25BBB147; 74) DYNDH1462B, UDI-DI: 10195327662462(each), 40195327662463(case), Lot Number: 24CBU138; 75) DYNDH1462B, UDI-DI: 10195327662462(each), 40195327662463(case), Lot Number: 24DBJ003; 76) DYNDH1462B, UDI-DI: 10195327662462(each), 40195327662463(case), Lot Number: 24DBP521; 77) DYNDH1462B, UDI-DI: 10195327662462(each), 40195327662463(case), Lot Number: 24EBA062; 78) DYNDH1462B, UDI-DI: 10195327662462(each), 40195327662463(case), Lot Number: 24EBU164; 79) DYNDH1462B, UDI-DI: 10195327662462(each), 40195327662463(case), Lot Number: 24FBD281; 80) DYNDH1462B, UDI-DI: 24FBK195(each), 10195327662462(case), Lot Number: 40195327662463; 81) DYNDH1462B, UDI-DI: 24FBS941(each), 10195327662462(case), Lot Number: 40195327662463; 82) DYNDH1462B, UDI-DI: 10195327662462(each), 40195327662463(case), Lot Number: 24GBH144; 83) DYNDH1462B, UDI-DI: 10195327662462(each), 40195327662463(case), Lot Number: 24GBX678; 84) DYNDH1462B, UDI-DI: 10195327662462(each), 40195327662463(case), Lot Number: 24HBG621; 85) DYNDH1462B, UDI-DI: 10195327662462(each), 40195327662463(case), Lot Number: 24HBJ952; 86) DYNDH1462B, UDI-DI: 10195327662462(each), 40195327662463(case), Lot Number: 24HBT054; 87) DYNDH1462B, UDI-DI: 10195327662462(each), 40195327662463(case), Lot Number: 24JBA557; 88) DYNDH1462B, UDI-DI: 10195327662462(each), 40195327662463(case), Lot Number: 25ABK267Z; 89) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 25ABC488; 90) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 25ABO279; 91) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24LBD413; 92) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24ABL303; 93) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24ABY205; 94) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24CBJ142; 95) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24CBT682; 96) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24EBI894; 97) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24FBS943; 98) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24GBT335; 99) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24IBL862; 100) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24IBV950; 101) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24JBB865; 102) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24JBI309; 103) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24KBE071; 104) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 23IBL873; 105) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 23JBH261; 106) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 23KBQ211; 107) DYNDH1620A, UDI-DI: 10195327216047(each), 40195327216048(case), Lot Number: 24LBU144; 108) DYNDH1620A, UDI-DI: 10195327216047(each), 40195327216048(case), Lot Number: 24LBI541; 109) DYNDH1620A, UDI-DI: 10195327216047(each), 40195327216048(case), Lot Number: 24DBO997; 110) DYNDH1620A, UDI-DI: 10195327216047(each), 40195327216048(case), Lot Number: 24GBC034; 111) DYNDH1620A, UDI-DI: 10195327216047(each), 40195327216048(case), Lot Number: 24KBH535; 112) DYNDH1620A, UDI-DI: 10195327216047(each), 40195327216048(case), Lot Number: 23KBV431; 113) DYNDH1622C, UDI-DI: 10195327509873(each), 40195327509874(case), Lot Number: 25EBD604; 114) DYNDH1622C, UDI-DI: 10195327509873(each), 40195327509874(case), Lot Number: 24ABK078; 115) DYNDH1622C, UDI-DI: 10195327509873(each), 40195327509874(case), Lot Number: 24BBB587; 116) DYNDH1622C, UDI-DI: 10195327509873(each), 40195327509874(case), Lot Number: 24BBV398; 117) DYNDH1622C, UDI-DI: 10195327509873(each), 40195327509874(case), Lot Number: 24CBJ143; 118) DYNDH1622C, UDI-DI: 10195327509873(each), 40195327509874(case), Lot Number: 24CBU661; 119) DYNDH1622C, UDI-DI: 10195327509873(each), 40195327509874(case), Lot Number: 24EBU004; 120) DYNDH1622C, UDI-DI: 10195327509873(each), 40195327509874(case), Lot Number: 24FBK924; 121) DYNDH1622C, UDI-DI: 10195327509873(each), 40195327509874(case), Lot Number: 24GBH140; 122) DYNDH1622C, UDI-DI: 10195327509873(each), 40195327509874(case), Lot Number: 24HBT637; 123) DYNDH1622C, UDI-DI: 10195327509873(each), 40195327509874(case), Lot Number: 24JBB866; 124) DYNDH1622C, UDI-DI: 10195327509873(each), 40195327509874(case), Lot Number: 24JBF575; 125) DYNDH1622C, UDI-DI: 10195327509873(each), 40195327509874(case), Lot Number: 23JBQ525; 126) DYNDH1622C, UDI-DI: 10195327509873(each), 40195327509874(case), Lot Number: 23KBW274; 127) DYNDH1622C, UDI-DI: 10195327509873(each), 40195327509874(case), Lot Number: 23LBL909; 128) DYNDH1622D, UDI-DI: 10198459234965(each), 40198459234966(case), Lot Number: 25GBA905; 129) DYNDH1622D, UDI-DI: 10198459234965(each), 40198459234966(case), Lot Number: 25HBN203; 130) DYNDH1626B, UDI-DI: 10195327323332(each), 40195327323333(case), Lot Number: 24LBI550; 131) DYNDH1626B, UDI-DI: 10195327323332(each), 40195327323333(case), Lot Number: 24ABI955; 132) DYNDH1626B, UDI-DI: 10195327323332(each), 40195327323333(case), Lot Number: 24BBB590; 133) DYNDH1626B, UDI-DI: 10195327323332(each), 40195327323333(case), Lot Number: 24CBJ146; 134...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide distribution.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Sep 9, 2026
Recall initiation date
Jun 12, 2026
Center classification date
Aug 31, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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