is it on recall

Recall archive / FDA device enforcement

Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: D... — FDA record Z-1366-2026

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 Dec 31, 2025. 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 Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SET, 15DRP, 1 INJECT PORT,, Model Number: DYNDTB1530; 5) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 6, Model Number: DYNDTB1539; 6) DBD-IV ADMIN SET, 15DRP, 3 NF, 109, Model Number: DYNDTB1545; 7) IV ADMIN SET, 20DRP, 3 NF, 109, Model Number: DYNDTB2045; 8) DBD-IVADMINSET60DRP2NEEDLE-FREEVLVE96, Model Number: DYNDTB0512; 9) DBD-IVADMINSET,60DRP3 NEEDLE-FREE VLVE11, Model Number: DYNDTB0555; 10) IV ADMIN SET, 10DRP, NF,INJ, 96, Model Number: DYNDTB1022; 11) DBD-IV ADMIN SET, 15DRP, 2NF, 96, Model Number: DYNDTB1512; 12) DBD-IV ADMIN SET, 15DRP, 1NF, 92, Model Number: DYNDTB1529; 13) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 9, Model Number: DYNDTB1537; 14) DBD-IV ADMIN SET, 15DRP, SECOND, 40, Model Number: DYNDTB1540; 15) IV ADMIN SET, 20DRP, 1NF, 92, Model Number: DYNDTB2029; 16) DBD-IV EXT SET, 6.5, 1.1ML, M LUERLOCK,, Model Number: DYNDTB5077; 17) IV ADMIN SET, 10DRP, 3 NF, 109, Model Number: DYNDTB1045; 18) DBD-IVADMISET15DRP4NEEDLEFREE VLVESTPCK1, Model Number: DYNDTB1545D; 19) IV ADMIN SET15DRPFLWCTRL1NEEDLEFREE VA, Model Number: DYNDTB2524; 20) IV ADMIN SET, 10DRP, 2NF, 96, Model Number: DYNDTB1012; 21) IV ADMIN SET, 20DRP, 2NF, 96, Model Number: DYNDTB2012; 22) IV ADMIN SET, 20DRP, NF,INJ, 96, Model Number: DYNDTB2022; 23) DBD-IV EXT SET,SMBORE EXT,8,M LUERLOCK,1, Model Number: DYNDTB5081
Reason
Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.
Classification
Class II
Recalling firm
Medline Industries, LP
Quantity
926,227 units
Agency-reported status
Ongoing
Source record identifier
Z-1366-2026

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) DYNDTB0529, UDI-DI: 10197344105663(each), 20197344105660(case), Lot Number: All Lot Numbers; 2) DYNDTB1029, UDI-DI: 10197344076956(each), 20197344076953(case), Lot Number: All Lot Numbers; 3) DYNDTB1516, UDI-DI: 10197344105687(each), 20197344105684(case), Lot Number: All Lot Numbers; 4) DYNDTB1530, UDI-DI: 10197344105694(each), 20197344105691(case), Lot Number: All Lot Numbers; 5) DYNDTB1539, UDI-DI: 10197344008254(each), 20197344008251(case), Lot Number: All Lot Numbers; 6) DYNDTB1545, UDI-DI: 10197344098644(each), 20197344098641(case), Lot Number: All Lot Numbers; 7) DYNDTB2045, UDI-DI: 10197344077007(each), 20197344077004(case), Lot Number: All Lot Numbers; 8) DYNDTB0512, UDI-DI: 10197344105656(each), 20197344105653(case), Lot Number: All Lot Numbers; 9) DYNDTB0555, UDI-DI: 10197344105670(each), 20197344105677(case), Lot Number: All Lot Numbers; 10) DYNDTB1022, UDI-DI: 10197344076949(each), 20197344076946(case), Lot Number: All Lot Numbers; 11) DYNDTB1512, UDI-DI: 10197344098613(each), 20197344098610(case), Lot Number: All Lot Numbers; 12) DYNDTB1529, UDI-DI: 10197344098620(each), 20197344098627(case), Lot Number: All Lot Numbers; 13) DYNDTB1537, UDI-DI: 10197344008247(each), 20197344008244(case), Lot Number: All Lot Numbers; 14) DYNDTB1540, UDI-DI: 10197344098637(each), 20197344098634(case), Lot Number: All Lot Numbers; 15) DYNDTB2029, UDI-DI: 10197344076994(each), 20197344076991(case), Lot Number: All Lot Numbers; 16) DYNDTB5077, UDI-DI: 10197344098651(each), 20197344098658(case), Lot Number: All Lot Numbers; 17) DYNDTB1045, UDI-DI: 10197344076963(each), 20197344076960(case), Lot Number: All Lot Numbers; 18) DYNDTB1545D, UDI-DI: 10197344105700(each), 20197344105707(case), Lot Number: All Lot Numbers; 19) DYNDTB2524, UDI-DI: 10197344105717(each), 20197344105714(case), Lot Number: All Lot Numbers; 20) DYNDTB1012, UDI-DI: 10197344076932(each), 20197344076939(case), Lot Number: All Lot Numbers; 21) DYNDTB2012, UDI-DI: 10197344076970(each), 20197344076977(case), Lot Number: All Lot Numbers; 22) DYNDTB2022, UDI-DI: 10197344076987(each), 20197344076984(case), Lot Number: All Lot Numbers; 23) DYNDTB5081, UDI-DI: 10197344098668(each), 20197344098665(case), Lot Number: All Lot Numbers

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

Distribution

Worldwide distribution - US Nationwide and the country of Bahamas.

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
Dec 31, 2025
Center classification date
Feb 13, 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.

Related records

Medical devices recordsMedline Industries, LP records