FDA Recalls high

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

Source: FDA · United States

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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 March 3, 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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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.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about? ▾
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.
Which agency issued this alert? ▾
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert? ▾
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected? ▾
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates? ▾
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.

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