Medline Industries Recalls Over 926,000 IV Administration and Extension Sets Due to Connector Failure
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Medline Industries, LP has issued a voluntary recall for nearly 1 million IV administration and extension sets because male luer connectors may leak or break, posing serious health risks.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
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:
- DYNDTB0529: DBD-IV ADMIN SET, 60DRP, 1 NEEDLE-FREE VALV
- DYNDTB1029: IV ADMIN SET, 10DRP, 1NF, 92
- DYNDTB1516: DBD-IVEXTSET 2.4ML 2 NEEDLE-FREE VLVE, 35
- DYNDTB1530: DBD-IV ADMIN SET, 15DRP, 1 INJECT PORT
- DYNDTB1539: DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 6
- DYNDTB1545: DBD-IV ADMIN SET, 15DRP, 3 NF, 109
- DYNDTB2045: IV ADMIN SET, 20DRP, 3 NF, 109
- DYNDTB0512: DBD-IV ADMIN SET 60DRP 2 NEEDLE-FREE VLVE 96
- DYNDTB0555: DBD-IV ADMIN SET, 60DRP 3 NEEDLE-FREE VLVE 11
- DYNDTB1022: IV ADMIN SET, 10DRP, NF, INJ, 96
- DYNDTB1512: DBD-IV ADMIN SET, 15DRP, 2NF, 96
- DYNDTB1529: DBD-IV ADMIN SET, 15DRP, 1NF, 92
- DYNDTB1537: DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 9
- DYNDTB1540: DBD-IV ADMIN SET, 15DRP, SECOND, 40
- DYNDTB2029: IV ADMIN SET, 20DRP, 1NF, 92
- DYNDTB5077: DBD-IV EXT SET, 6.5, 1.1ML, M LUERLOCK
- DYNDTB1045: IV ADMIN SET, 10DRP, 3 NF, 109
- DYNDTB1545D: DBD-IV ADMI SET 15DRP 4 NEEDLEFREE VLVESTPCK1
- DYNDTB2524: IV ADMIN SET 15DRP FLWCTRL 1 NEEDLEFREE VA
- DYNDTB1012: IV ADMIN SET, 10DRP, 2NF, 96
- DYNDTB2012: IV ADMIN SET, 20DRP, 2NF, 96
- DYNDTB2022: IV ADMIN SET, 20DRP, NF, INJ, 96
- 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.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.