FDA recall, , Moderate risk
Medline IV Administration and Extension Sets
IV administration and extension sets may leak, crack, or break, causing treatment delays, blood loss, infection, air embolism, or underdosage.
Summary by Recall Canary from the FDA notice
What happened
Medline Industries, LP, of Northfield, Illinois, recalled IV Administration and Extension Sets because the male luer connectors may leak, crack, and/or break during use under circumstances involving exposure to particular chemicals and mechanical forces. This may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication. The recall began on December 31, 2025, and was added to the FDA's Enforcement Report on February 13, 2026.
The recalled products include models such as DYNDTB0529, DYNDTB1029, DYNDTB1516, DYNDTB1530, DYNDTB1539, DYNDTB1545, and others. The sets were distributed worldwide, including the US Nationwide and the country of Bahamas. The company initiated the recall for these products.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your set affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medline Industries IV Administration and Extension Sets: 1) DBD-IV Admin Set,60DRP,1NEEDLE-Free Valv
- Model
- DYNDTB0529
- UDI-DI
- 10197344105663
- 20197344105660
- 10197344076956
- 20197344076953
- 10197344105687
- 20197344105684
- 10197344105694
- 20197344105691
- 10197344008254
- 20197344008251
- 10197344098644
- 20197344098641
- 10197344077007
- 20197344077004
- 10197344105656
- 20197344105653
- 10197344105670
- 20197344105677
- 10197344076949
- 20197344076946
- 10197344098613
- 20197344098610
- 10197344098620
- 20197344098627
- 10197344008247
- 20197344008244
- 10197344098637
- 20197344098634
- 10197344076994
- 20197344076991
- 10197344098651
- 20197344098658
- 10197344076963
- 20197344076960
- 10197344105700
- 20197344105707
- 10197344105717
- 20197344105714
- 10197344076932
- 20197344076939
- 10197344076970
- 20197344076977
- 10197344076987
- 20197344076984
- 10197344098668
- 20197344098665
- Lot code
- All Lot Numbers, 2) DYNDTB1029, UDI-DI: 10197344076956(each), 20197344076953(case), Lot Number: All Lot Numbers, 3) DYNDTB1516, UDI-DI: 10197344105687(each), 20197344105684(case), 4) DYNDTB1530, UDI-DI: 10197344105694(each), 20197344105691(case), 5) DYNDTB1539, UDI-DI: 10197344008254(each), 20197344008251(case), 6) DYNDTB1545, UDI-DI: 10197344098644(each), 20197344098641(case), 7) DYNDTB2045, UDI-DI: 10197344077007(each), 20197344077004(case), 8) DYNDTB0512, UDI-DI: 10197344105656(each), 20197344105653(case), 9) DYNDTB0555, UDI-DI: 10197344105670(each), 20197344105677(case), 10) DYNDTB1022, UDI-DI: 10197344076949(each), 20197344076946(case), 11) DYNDTB1512, UDI-DI: 10197344098613(each), 20197344098610(case), 12) DYNDTB1529, UDI-DI: 10197344098620(each), 20197344098627(case), 13) DYNDTB1537, UDI-DI: 10197344008247(each), 20197344008244(case), 14) DYNDTB1540, UDI-DI: 10197344098637(each), 20197344098634(case), 15) DYNDTB2029, UDI-DI: 10197344076994(each), 20197344076991(case), 16) DYNDTB5077, UDI-DI: 10197344098651(each), 20197344098658(case), 17) DYNDTB1045, UDI-DI: 10197344076963(each), 20197344076960(case), 18) DYNDTB1545D, UDI-DI: 10197344105700(each), 20197344105707(case), 19) DYNDTB2524, UDI-DI: 10197344105717(each), 20197344105714(case), 20) DYNDTB1012, UDI-DI: 10197344076932(each), 20197344076939(case), 21) DYNDTB2012, UDI-DI: 10197344076970(each), 20197344076977(case), 22) DYNDTB2022, UDI-DI: 10197344076987(each), 20197344076984(case), 23) DYNDTB5081, UDI-DI: 10197344098668(each), 20197344098665(case)
IV Admin Set, 10DRP, 1NF, 92
- Model
- DYNDTB1029
DBD-IVEXTSET2.4ML2 Needle-Freevlve,35
- Model
- DYNDTB1516
DBD-IV Admin Set, 15DRP, 1 Inject Port
- Model
- DYNDTB1530
DBD-IV Admin Set, 15DRP, Roller Clamp, 6
- Model
- DYNDTB1539
DBD-IV Admin Set, 15DRP, 3 NF, 109
- Model
- DYNDTB1545
IV Admin Set, 20DRP, 3 NF, 109
- Model
- DYNDTB2045
DBD-IVADMINSET60DRP2NEEDLE-FREEVLVE96
- Model
- DYNDTB0512
DBD-Ivadminset,60DRP3 Needle-Free VLVE11
- Model
- DYNDTB0555
IV Admin Set, 10DRP, NF,INJ, 96
- Model
- DYNDTB1022
Show the other 13 products
DBD-IV Admin Set, 15DRP, 2NF, 96
- Model
- DYNDTB1512
DBD-IV Admin Set, 15DRP, 1NF, 92
- Model
- DYNDTB1529
DBD-IV Admin Set, 15DRP, Roller Clamp, 9
- Model
- DYNDTB1537
DBD-IV Admin Set, 15DRP, Second, 40
- Model
- DYNDTB1540
IV Admin Set, 20DRP, 1NF, 92
- Model
- DYNDTB2029
DBD-IV EXT Set, 6.5, 1.1ML, M Luerlock
- Model
- DYNDTB5077
IV Admin Set, 10DRP, 3 NF, 109
- Model
- DYNDTB1045
DBD-IVADMISET15DRP4NEEDLEFREE VLVESTPCK1
- Model
- DYNDTB1545D
IV Admin SET15DRPFLWCTRL1NEEDLEFREE VA
- Model
- DYNDTB2524
IV Admin Set, 10DRP, 2NF, 96
- Model
- DYNDTB1012
IV Admin Set, 20DRP, 2NF, 96
- Model
- DYNDTB2012
IV Admin Set, 20DRP, NF,INJ, 96
- Model
- DYNDTB2022
DBD-IV EXT Set,Smbore EXT,8,M Luerlock,1
- Model
- DYNDTB5081
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the country of Bahamas.
- Company
- Medline Industries, LPNorthfield, Illinois
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98299
- Recall number
- Z-1366-2026
- Quantity recalled
- 926,227 units
All recalls from Medline Industries, LP
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
