Medline Industries Recalls Over 926,000 IV Administration and Extension Sets Due to Connector Failure

What Happened

Medline Industries, LP has initiated a voluntary recall of various IV Administration and Extension sets. The recall was prompted by findings that, under certain circumstances involving exposure to specific chemicals and mechanical forces, the male luer connectors on these devices may leak, crack, or break during use.

Which Products Are Affected

A total of 926,227 units are affected by this recall. The distribution includes nationwide coverage in the United States and the Bahamas. The recall includes all lot numbers for the following 23 model numbers:

1. DYNDTB0529: DBD-IV ADMIN SET, 60DRP, 1 NEEDLE-FREE VALV
2. DYNDTB1029: IV ADMIN SET, 10DRP, 1NF, 92
3. DYNDTB1516: DBD-IVEXTSET 2.4ML 2 NEEDLE-FREE VLVE, 35
4. DYNDTB1530: DBD-IV ADMIN SET, 15DRP, 1 INJECT PORT
5. DYNDTB1539: DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 6
6. DYNDTB1545: DBD-IV ADMIN SET, 15DRP, 3 NF, 109
7. DYNDTB2045: IV ADMIN SET, 20DRP, 3 NF, 109
8. DYNDTB0512: DBD-IV ADMIN SET 60DRP 2 NEEDLE-FREE VLVE 96
9. DYNDTB0555: DBD-IV ADMIN SET, 60DRP 3 NEEDLE-FREE VLVE 11
10. DYNDTB1022: IV ADMIN SET, 10DRP, NF, INJ, 96
11. DYNDTB1512: DBD-IV ADMIN SET, 15DRP, 2NF, 96
12. DYNDTB1529: DBD-IV ADMIN SET, 15DRP, 1NF, 92
13. DYNDTB1537: DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 9
14. DYNDTB1540: DBD-IV ADMIN SET, 15DRP, SECOND, 40
15. DYNDTB2029: IV ADMIN SET, 20DRP, 1NF, 92
16. DYNDTB5077: DBD-IV EXT SET, 6.5, 1.1ML, M LUERLOCK
17. DYNDTB1045: IV ADMIN SET, 10DRP, 3 NF, 109
18. DYNDTB1545D: DBD-IV ADMI SET 15DRP 4 NEEDLEFREE VLVESTPCK1
19. DYNDTB2524: IV ADMIN SET 15DRP FLWCTRL 1 NEEDLEFREE VA
20. DYNDTB1012: IV ADMIN SET, 10DRP, 2NF, 96
21. DYNDTB2012: IV ADMIN SET, 20DRP, 2NF, 96
22. DYNDTB2022: IV ADMIN SET, 20DRP, NF, INJ, 96
23. DYNDTB5081: DBD-IV EXT SET, SMBORE EXT, 8, M LUERLOCK, 1

What You Should Do

Medline Industries, LP began notifying customers of the recall via a formal letter on December 31, 2025. Healthcare facilities and consumers should immediately check their inventory for the model numbers listed above. Affected products should be identified and handled according to the instructions provided in the firm’s notification letter. For further assistance, contact Medline Industries, LP at their Northfield, IL headquarters.

Why This Matters

Failure of the male luer connectors can lead to serious medical complications, including blood loss, infection, air embolism, or the underdosage of critical medication. These failures can also result in significant delays in patient treatment.

Source

Information provided by the FDA. Recall Number: Z-1366-2026.