Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number... — FDA record Z-2094-2026

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 Jan 7, 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) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number:ACC010487; 5) PEDS PICC INSERTION TRAY, Model Number:CVI3650; 6) LINE ATTIRE KIT, Model Number:DYKM2170; 7) PK BNDL CENT LINE PROTECT KIT, Model Number:DYKM2274; 8) KIT SURG ONC LAP DIAG/PORT INS, Model Number:DYKMBNDL153C; 9) KIT SURG ONC INSERT CENT.VENOU, Model Number:DYKMBNDL43A; 10) KIT SURG ONC PORT INSERTION, Model Number:DYKMBNDL43C; 11) VEIN PROCEDURE KIT, Model Number:DYNDA2076B; 12) VEIN PROCEDURE KIT, Model Number:DYNDA2076D; 13) VEIN PROCEDURE KIT, Model Number:DYNDA2076F; 14) PLACENTA KIT, Model Number:DYNDA2322B; 15) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407A; 16) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407B; 17) PICC LINE TRAY, Model Number:DYNJ40500A; 18) VENOUS ACCESS PACK, Model Number:DYNJ42694C; 19) AV FISTULA CREATION PACK-LF, Model Number:DYNJ53427B; 20) PICC LINE, Model Number:DYNJ55546D; 21) PICC TRAY, Model Number:DYNJ63199A; 22) PICC KIT 4F SL PL MAX BARRIER, Model Number:DYNJ70141MB; 23) PICC KIT 5F DL PL MB, Model Number:DYNJ70152MB; 24) VEIN PACK, Model Number:DYNJ84239; 25) NEXTON PACK, Model Number:DYNJ88152; 26) PICC INSERTION TRAY W/O CATH, Model Number:PICCNC0004
Reason
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Classification
Class II
Recalling firm
Medline Industries, LP
Quantity
5562 units
Agency-reported status
Ongoing
Source record identifier
Z-2094-2026

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) 00-401993O, UDI-DI: 10195327517366(each), 40195327517367(case), Lot Number: 23KBH528; 2) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21BDB379; 3) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21CDB078; 4) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21IDC222; 5) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21JDB458; 6) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22ADC105; 7) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22BDA862; 8) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22CDC433; 9) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22DDA763; 10) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22FDB218; 11) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23BDB271; 12) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23DDA455; 13) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23DDB175; 14) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23FDC048; 15) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23GDB567; 16) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23IDA297; 17) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 24DDA188; 18) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24HDB961; 19) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24IDB060; 20) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24JDB298; 21) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24KDA478; 22) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 25DDB786; 23) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 25EDA196; 24) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 21CDC422; 25) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 21LDB744; 26) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 22BDB354; 27) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23EDB085; 28) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23FDB587; 29) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDA369; 30) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDB672; 31) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDB680; 32) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23HDA348; 33) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25ADB553; 34) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25BDA733; 35) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25BDB580; 36) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25HDA748; 37) CVI3650, UDI-DI: 10653160256397(each), 40653160256398(case), Lot Number: 22EBO541; 38) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 22IBN124; 39) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 23ABC583; 40) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 23BBA792; 41) DYKM2274, UDI-DI: 10198459278884(each), 40198459278885(case), Lot Number: 25HBK806; 42) DYKMBNDL153C, UDI-DI: 10198459000430(each), 40198459000431(case), Lot Number: 24DBR907; 43) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 22IBK412; 44) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 22IBM493; 45) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 23ABK335; 46) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 23BBS866; 47) DYKMBNDL43C, UDI-DI: 10198459000553(each), 40198459000554(case), Lot Number: 24DBS686; 48) DYNDA2076B, UDI-DI: 10195327572020(each), 40195327572021(case), Lot Number: 24ABI534; 49) DYNDA2076D, UDI-DI: 10198459216060(each), 40198459216061(case), Lot Number: 24LMH364; 50) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25FMF582; 51) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25HMH651; 52) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25IMA505; 53) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25KMH542; 54) DYNDA2322B, UDI-DI: 10195327299774(each), 40195327299775(case), Lot Number: 23FBW064; 55) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21ABI600; 56) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21DBA072; 57) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21JBV496; 58) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21LBT037; 59) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21OBA058; 60) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 22FME865; 61) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 23HMC992; 62) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24AMB024; 63) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24CMI922; 64) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24DMF048; 65) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24IMD214; 66) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 25EMA699; 67) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 25FMG170; 68) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 25IMA418; 69) DYNJ40500A, UDI-DI: 10195327350581(each), 40195327350582(case), Lot Number: 23FBG757; 70) DYNJ40500A, UDI-DI: 10195327350581(each), 40195327350582(case), Lot Number: 23HBB480; 71) DYNJ42694C, UDI-DI: 10195327514334(each), 40195327514335(case), Lot Number: 24ABW686; 72) DYNJ53427B, UDI-DI: 10193489248227(each), 40193489248228(case), Lot Number: 20LDC151; 73) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 22IBQ424; 74) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 22LBG357; 75) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 23BBB100; 76) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 23CBT475; 77) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 23GBK664; 78) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 22BBP290; 79) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 22IBO930; 80) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 22JBN171; 81) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 24EBG970; 82) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 25CBK996; 83) DYNJ70141MB, UDI-DI: 10889942722808(each), 40889942722809(case), Lot Number: 21ADA546; 84) DYNJ70152MB, UDI-DI: 10889942722822(each), 40889942722823(case), Lot Number: 21ADA547; 85) DYNJ84239, UDI-DI: 10195327345624(each), 40195327345625(case), Lot Number: 23FBJ937; 86) DYNJ88152, UDI-DI: 10198459110313(each), 40198459110314(case), Lot Number: 24IBL774; 87) DYNJ88152, UDI-DI: 10198459110313(each), 40198459110314(case), Lot Number: 24JBC005; 88) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 22CBY021; 89) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 22EBG055; 90) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 22LME863; 91) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23BMF790; 92) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23EMF082; 93) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23JMG079; 94) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23JMI718; 95) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23LMA136; 96) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23LMD502

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

Distribution

Worldwide - 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
May 13, 2026
Recall initiation date
Jan 7, 2026
Center classification date
May 7, 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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