Use cautionMedical device recall · FDA · Published December 31, 2025
Medline IV Sets May Leak Chemicals and Break, Risking Patient Harm
Medline recalls 23 IV administration sets that may leak, crack, or break during use, potentially causing blood loss, infection, or medication underdose. Affected models include DBD-IV ADMIN SET, 60DRP, and others with specific model numbers.
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.
Take action
Contact the company
📍Recalling firmMedline Industries, LP3 Lakes Dr · Northfield, IL 60093-2753
“Medline IV Sets May Leak Chemicals and Break, Risking Patient Harm.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50327-medline-iv-sets-may-leak-chemicals-and-break-risking-patient. Based on FDA recall #Z-1366-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1366-2026%22&limit=1).
The FDA announced on Dec. 31, 2025, that Medline Industries, LP is recalling IV Administration and Extension Sets due to potential connector leaks, cracks, or breaks that may cause treatment delays, blood loss, infection, air embolism, or underdosage. The agency issued recall number Z-1366-2026 for the voluntary Class II recall affecting 926,227 units distributed worldwide.
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. This failure may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.
Context
GovInfoNow's records show Medline Industries, LP has had 68 other recalls since July 31, 2025. Recent Medline recalls include a Aug. 14, 2026, recall of Basic Homecare Beds for potential fire hazards and an Aug. 11, 2026, recall of Convenience Kits for fungal contamination risk. Other recent recalls of similar products include B Braun Medical IV Sets: Risk of Medication Backflow and Occlusion (2025-10-29) and B Braun SAFELINE IV Sets: Risk of Medication Backflow and Occlusion (2025-10-29).
How to tell if you have this one
Check for model numbers DYNDTB0529 through DYNDTB5081 listed in the recall. These sets were sold with all lot numbers from 2019 to 2020.
Brand
Medline
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Model Numbers
Look for model numbers DYNDTB0529 to DYNDTB5081 on the IV sets. These are the affected products.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the country of Bahamas.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 56 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1366-2026 (December 31, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1366-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.