CLASS II ONGOING Device recall · Reported 25 Feb 2026 · FDA Enforcement Report
IV Administration and Extension Sets recalled by Medline Industries
Medline Industries is recalling IV Administration and Extension Sets: Dbd-iv Admin Set,60DRP,1NEEDLE-Free Valv, distributed nationwide in the US. The recall was initiated on 31 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1366-2026
- FDA event ID
- 98299
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Dec 2025
- FDA classified
- 13 Feb 2026
- Reported
- 25 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Syringes & Needles
Timeline
| 31 Dec 2025 | Recall initiated by company | |
| 13 Feb 2026 | Classified by FDA | +44 days |
| 25 Feb 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the country of Bahamas.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
1) 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
Where was it sold?
Worldwide distribution - US Nationwide and the country of Bahamas.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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