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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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.
Recall announced
December 31, 2025
Reported by FDA DEVICE
February 25, 2026
RecallRadar source check
March 4, 2026
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
- Check the model number on the product packaging or device
- Compare it with the recalled model numbers listed in the recall notice
- 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
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Safety Guide
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