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Medline Industries Recalls IV Administration Sets Due to Leakage Risk

Medline Industries recalled over 926,000 IV Administration and Extension Sets due to a significant risk of leaks and breaks. The recall affects multiple models with potential exposure to chemicals and mechanical forces. Users should discontinue use immediately to prevent serious health risks including blood loss and infections.

Official notice
Medline Industries, LPHealth & Personal CareMedical Devices1) DYNDTB0529UDI-DI: 10197344105663(each)20197344105660(case)

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
December 31, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
December 31, 2025
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Medline Industries, LP
Product type
IV Administration and Extension Sets
Model numbers
1) DYNDTB0529, UDI-DI: 10197344105663(each), 20197344105660(case), Lot Number: All Lot Numbers, 2) DYNDTB1029, UDI-DI: 10197344076956(each), 20197344076953(case), 3) DYNDTB1516 +8 more
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    December 31, 2025

  2. Reported by FDA DEVICE

    February 25, 2026

  3. RecallRadar source check

    March 4, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter

About This Product

IV Administration and Extension Sets are critical medical devices used to deliver fluids and medications directly into a patient's bloodstream. Healthcare providers rely on these sets for safe and effective patient treatment in various medical settings.

Why This Is Dangerous

The male luer connectors on these IV sets may fail under certain conditions, leading to leaks or breaks. This defect can compromise patient safety by delaying treatment and increasing the risk of infections and other complications.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

This recall poses significant risks to patients requiring IV treatments, with potential delays in care and serious health consequences. Users must act quickly to ensure their safety.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on the product packaging or device
  2. Compare it with the recalled model numbers listed in the recall notice
  3. If it matches, discontinue use immediately

Where to find product info

The model number can usually be found on the product packaging or printed on the device itself, often near the connector area or on the label.

What timeline to expect

Expect a realistic timeline of 4-6 weeks for refund processing once the recalled product is returned.

If the manufacturer is unresponsive

  • Document all attempts to contact Medline Industries
  • Reach out through alternate contact methods if there is no response
  • Consider filing a complaint with the FDA if issues persist.

How to prevent similar issues

  • Research safety certifications for IV Administration Sets before purchase
  • Choose products from reputable manufacturers with a history of safety compliance
  • Read reviews and safety records of similar products before buying.

Documentation advice

Keep all correspondence related to the recall, including emails and letters. Document the model number and take photos of the product for your records.

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Product Details

The recall encompasses 23 models of IV Administration and Extension Sets, including model numbers DYNDTB0529, DYNDTB1029, and DYNDTB1516. These products were distributed worldwide, including throughout the United States and the Bahamas. The products were sold from various healthcare suppliers.

Key Facts

  • Over 926,000 units recalled
  • Risk of leaks and breaks in connectors
  • Potential for serious health complications
  • Discontinue use immediately
  • Contact Medline for further instructions

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeIV Administration and Extension Sets
Sold At
Multiple Retailers

Product Details

Model Numbers
1) DYNDTB0529
UDI-DI: 10197344105663(each)
20197344105660(case)
Lot Number: All Lot Numbers
2) DYNDTB1029
+11 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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