Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model ... — FDA record Z-1399-2026

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) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER #5, Model Number: ACC010475; 4) DRAWER 1 NEURO CART, Model Number: ACC010542; 5) DRAWER 2 NEURO CART, Model Number: ACC010543; 6) DRAWER 4, Model Number: ACC010722; 7) MALIGNANT HYPERTHERMIA CART, Model Number: ACC010896; 8) LIVER TRANSPLANT #57 CDS-2, Model Number: CDS860063U; 9) THOROCOTOMY CDS #24-RF, Model Number: CDS860066T; 10) CYSTO, Model Number: CDS981795G; 11) MAJOR PROCEDURE CDS, Model Number: CDS982414N; 12) TOTAL KNEE CDS, Model Number: CDS982823R; 13) VASCULAR CDS-1, Model Number: CDS982895I; 14) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069F; 15) HEART CABG CDS, Model Number: CDS983376S; 16) CRANIOTOMY, Model Number: CDS983611N; 17) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653K; 18) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653L; 19) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653M; 20) MAJOR ABDOMINAL CDS, Model Number: CDS983908Q; 21) NHP ROBOTIC GENERAL CDS, Model Number: CDS984244I; 22) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431M; 23) MAJOR ABDOMINAL CDS (NO GOWNS), Model Number: CDS985557L; 24) PREP KIT, Model Number: DYK1022113CP; 25) BARRIER KIT,UNIV OF ALABAMA, Model Number: DYK1060193B; 26) PERSONAL ITEM KIT, Model Number: DYKA1131; 27) GI PACK, Model Number: DYKE1441D; 28) GI PACK, Model Number: DYKE1441G; 29) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456C; 30) VIDEO BRONCHOSCOPY TRAY, Model Number: DYKE1666; 31) GI LAB OTHER ENDO KIT, Model Number: DYKE1721A; 32) MATERNITY KIT, Model Number: DYKL1343; 33) BUNNY KIT, Model Number: DYKM1054C; 34) ASST STERILE PPE, Model Number: DYKM1270; 35) MASK CAP AND GOWN KIT, Model Number: DYKM1427A; 36) BLOOD PRECAUTION KIT, Model Number: DYKM1687; 37) HELPERS KIT, Model Number: DYKM1832; 38) BRONCHOSPY SUPPLY KIT, Model Number: DYKM1898; 39) OP UROLOGY KIT, Model Number: DYKM2316; 40) ICU PACK, Model Number: DYKM2671; 41) KIT OMF LEFORTE, Model Number: DYKMBNDL1; 42) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103; 43) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103A; 44) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103B; 45) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115; 46) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115A; 47) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115B; 48) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116C; 49) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117B; 50) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121D; 51) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121G; 52) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121I; 53) KIT ACES INSERT PEG, Model Number: DYKMBNDL130B; 54) KIT OMF PEDS MINOR, Model Number: DYKMBNDL139; 55) KIT THOR ESOPH PERF.REPAIR, Model Number: DYKMBNDL140; 56) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142A; 57) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146A; 58) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DY...
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
154427 units
Agency-reported status
Ongoing
Source record identifier
Z-1399-2026

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) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 22HDA973; 2) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 22BDB172; 3) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21LDA438; 4) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21CDB692; 5) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21CDB175; 6) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24GDA256; 7) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 23IDB293; 8) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23EDC028; 9) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23EDB192; 10) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23EDA657; 11) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 22LDA361; 12) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 22KDB086; 13) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 22JDB707; 14) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 21BDA319; 15) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 24DDA266; 16) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 23JDA838; 17) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 22FDB178; 18) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 22DDB648; 19) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 21KDA051; 20) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 25KDB023; 21) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 25JDB588; 22) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 23JDB732; 23) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 23CDB042; 24) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 22EDA459; 25) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 22CDA899; 26) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 21KDB787; 27) ACC010722, UDI-DI: 10195327472412(each), 40195327472413(case), Lot Number: 23JDC381; 28) ACC010722, UDI-DI: 10195327472412(each), 40195327472413(case), Lot Number: 23JDB244; 29) ACC010896, UDI-DI: 10198459166815(each), 40198459166816(case), Lot Number: 24LDA583; 30) CDS860063U, UDI-DI: 10195327148638(each), 40195327148639(case), Lot Number: 23LBO008; 31) CDS860066T, UDI-DI: 10195327107741(each), 40195327107742(case), Lot Number: 23LBK545; 32) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 24GBK408; 33) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 24BBL254; 34) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 23JBS427; 35) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 23EBW445; 36) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 23EBH164; 37) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 23CBG007; 38) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 23ABD835; 39) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 22KBV668; 40) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 22JBH118; 41) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 22HBM408; 42) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 22DBF114; 43) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 21LBE721; 44) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 21IBP643; 45) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 21FBT373; 46) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 21DBC918; 47) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 21BBE784; 48) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 22OBM444; 49) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 22GBH219; 50) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 22BBB915; 51) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 21IBL978; 52) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 21GBE905; 53) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 21FBG328; 54) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 21DBU729; 55) CDS982823R, UDI-DI: 10195327584481(each), 40195327584482(case), Lot Number: 24CBI679; 56) CDS982823R, UDI-DI: 10195327584481(each), 40195327584482(case), Lot Number: 24BBG787; 57) CDS982895I, UDI-DI: 10889942207688(each), 40889942207689(case), Lot Number: 21EBA011; 58) CDS983069F, UDI-DI: 10889942773558(each), 40889942773559(case), Lot Number: 21EBK915; 59) CDS983069F, UDI-DI: 10889942773558(each), 40889942773559(case), Lot Number: 21BBN554; 60) CDS983069F, UDI-DI: 10889942773558(each), 40889942773559(case), Lot Number: 20LBY313; 61) CDS983376S, UDI-DI: 10195327651886(each), 40195327651887(case), Lot Number: 24LMA929; 62) CDS983376S, UDI-DI: 10195327651886(each), 40195327651887(case), Lot Number: 24GMB750; 63) CDS983376S, UDI-DI: 10195327651886(each), 40195327651887(case), Lot Number: 24FMG753; 64) CDS983376S, UDI-DI: 10195327651886(each), 40195327651887(case), Lot Number: 24FMG397; 65) CDS983376S, UDI-DI: 10195327651886(each), 40195327651887(case), Lot Number: 24FMC832; 66) CDS983611N, UDI-DI: 10195327466626(each), 40195327466627(case), Lot Number: 24BBI517; 67) CDS983653K, UDI-DI: 10198459041136(each), 40198459041137(case), Lot Number: 24JBO747; 68) CDS983653K, UDI-DI: 10198459041136(each), 40198459041137(case), Lot Number: 24IBK669; 69) CDS983653K, UDI-DI: 10198459041136(each), 40198459041137(case), Lot Number: 24HBF890; 70) CDS983653K, UDI-DI: 10198459041136(each), 40198459041137(case), Lot Number: 24GBJ030; 71) CDS983653L, UDI-DI: 10198459235306(each), 40198459235307(case), Lot Number: 25EBM995; 72) CDS983653L, UDI-DI: 10198459235306(each), 40198459235307(case), Lot Number: 25DBF562; 73) CDS983653L, UDI-DI: 10198459235306(each), 40198459235307(case), Lot Number: 25CBF099; 74) CDS983653L, UDI-DI: 10198459235306(each), 40198459235307(case), Lot Number: 25ABT992; 75) CDS983653M, UDI-DI: 10198459413292(each), 40198459413293(case), Lot Number: 25HBB402; 76) CDS983908Q, UDI-DI: 10195327584450(each), 40195327584451(case), Lot Number: 24ABS333; 77) CDS984244I, UDI-DI: 10889942842148(each), 40889942842149(case), Lot Number: 21CBF877; 78) CDS985431M, UDI-DI: 10198459037801(each), 40198459037802(case), Lot Number: 24HBA354; 79) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 23BBG723; 80) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 22HBS739; 81) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 22HBJ007; 82) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 22GBY286; 83) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 22FBW150; 84) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 22DBJ805; 85) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 21JBZ371; 86) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 21IBC926; 87) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 21GBL281; 88) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 21EBO754; 89) DYK1022113CP, UDI-DI: 10080196110773(each), 40080196110774(case), Lot Number: 25AMB800; 90) DYK1022113CP, UDI-DI: 10080196110773(each), 40080196110774(case), Lot Number: 23LMI081; 91) DYK1022113CP, UDI-DI: 10080196110773(each), 40080196110774(case), Lot Number: 20LMD225; 92) DYK1022113CP, UDI-DI: 10080196110773(each), 40080196110774(case), Lot Number: 20LMC553; 93) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 25CBC746; 94) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 24KBP439; 95) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 24JBA718; 96) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 24GBG009; 97) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 24EBJ092; 98) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 24CBD288; 99) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 24ABO807; 100) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 23LBH944; 101) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 23KBI856; 102) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 23HBQ265; 103) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 23FBG126; 104) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 23EBK977; 105) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 23CBW954; 106) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 23BBA942; 107) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 22LBK107; 108) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 22JBQ642; 109) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 22HBW429; 110) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 22GBB583; 111) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 22EBG095; 112) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 22CBB236; 113) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 22BBL267; 114) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 22ABB932; 115) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 21KBG247; 116) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 21JBM301; 117) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 21IBT308; 118) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 21CBP418; 119) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 21BBN188; 120) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 21ABO769; 121) DYKA1131, UDI-DI: 10888277991262(each), 40888277991263(case), Lot Number: 22AFA117; 122) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 22JME976; 123) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 22HMA346; 124) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 22EMH722; 125) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 22DMA777; 126) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 21KMI229; 127) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 21IMH528; 128) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 21HMC199; 129) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 21GMD509; 130) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 21FMC679; 131) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 21EBO411; 132) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 21DBB848; 133) DYKE1441G, UDI-DI: 10198459003073(each), 40198459003074(case), Lot Number: 24FMI903; 134) DY...

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

Worldwide distribution - US Nationwide.

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
Feb 25, 2026
Recall initiation date
Jan 7, 2026
Center classification date
Feb 17, 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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