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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Surgical Equipment

Medline IV Administration and Extension Sets Recalled for Leaking or Breaking

Agency Publication Date: February 13, 2026
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Summary

Medline Industries is recalling 926,227 IV Administration and Extension Sets because the male connector (luer lock) may leak, crack, or break when exposed to certain chemicals or physical stress. This defect can lead to serious issues including patient treatment delays, blood loss, infection, air in the bloodstream (air embolism), or medication underdosage. These products were distributed nationwide in the U.S. and in the Bahamas.

Risk

The connector can fail during use, which may cause the IV line to disconnect or leak, potentially allowing air to enter the patient's bloodstream or causing the patient to receive the wrong amount of life-saving medication.

What You Should Do

  1. Check the model number and Unique Device Identifier (UDI) on your IV set packaging to see if your product is affected.
  2. Identify the specific product by checking for model numbers such as DYNDTB0529, DYNDTB1029, DYNDTB1516, DYNDTB1530, DYNDTB1539, and others. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product.
  4. Contact Medline Industries, LP or your distributor to arrange for a return, replacement, or correction of the device.
  5. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medline Industries IV Administration and Extension Sets
Model / REF:
DYNDTB0529
DYNDTB1029
DYNDTB1516
DYNDTB1530
DYNDTB1539
DYNDTB1545
DYNDTB2045
DYNDTB0512
DYNDTB0555
DYNDTB1022
DYNDTB1512
DYNDTB1529
DYNDTB1537
DYNDTB1540
DYNDTB2029
DYNDTB5077
DYNDTB1045
DYNDTB1545D
DYNDTB2524
DYNDTB1012
DYNDTB2012
DYNDTB2022
DYNDTB5081
Lot Numbers:
All Lot Numbers
UDI:
10197344105663
20197344105660
10197344076956
20197344076953
10197344105687
20197344105684
10197344105694
20197344105691
10197344008254
20197344008251
10197344098644
20197344098641
10197344077007
20197344077004
10197344105656
20197344105653
10197344105670
20197344105677
10197344076949
20197344076946
10197344098613
20197344098610
10197344098620
20197344098627
10197344008247
20197344008244
10197344098637
20197344098634
10197344076994
20197344076991
10197344098651
20197344098658
10197344076963
20197344076960
10197344105700
20197344105707
10197344105717
20197344105714
10197344076932
20197344076939
10197344076970
20197344076977
10197344076987
20197344076984
10197344098668
20197344098665

Includes various administration sets, extension sets, and sets with needle-free valves and flow controllers.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98299
Status: Active
Manufacturer: Medline Industries, LP
Sold By: Hospitals; Clinics; Medical distributors
Manufactured In: United States
Units Affected: 926,227 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.