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FDA recall, , Moderate risk

Medline Hudson RCI Heated Neonatal Breathing Circuits

Neonatal and infant heated wire breathing circuits may experience sporadic failure.

Summary by Recall Canary from the FDA notice

What happened

Medline Industries, LP, of Northfield, Illinois, recalled Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits nationwide on July 13, 2026, due to sporadic failure of the heated wire connector (pigtail) at the humidifier, which may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. The recall was announced on August 5, 2026, and added to the FDA's Enforcement Report on August 21, 2026.

The affected circuits include Medline Hudson RCI products with SKUs such as HUD78019, HUD78001KIT, HUD78007KIT, HUD78008KIT, HUD78007, HUD78009, and 780-13, among others. Distribution was worldwide, including the U.S. nationwide and Panama.

More device defect recalls

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What to do

If a code on your device is listed below:

  1. Consumers who have the affected Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits should stop using and discard the device.
  2. Do not return product to Medline.
  3. Consumers with questions regarding this recall can contact Medline by phone at 866-359-1704 Monday through Friday between the hours of 8am and 5pm CST or recalls@medline.com.
  4. Contact your physician or healthcare provider if you have experienced any problems that may be related to using this medical device.

Is yours affected?

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Medline Hudson RCI, DBD-Circuit,Vent,Inspiratory,Heated,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit

    UDI-DI
    • 10197344010752
    • 20197344010759
    • 10197344010738
    • 20197344010735
    • 10197344010721
    • 20197344010728
    • 10197344010714
    • 20197344010711
    • 10197344010677
    • 20197344010674
    • 10197344010905
    • 20197344010902
    • 10197344010929
    • 20197344010926
    • 10197344010493
    • 20197344010490
    • 10197344010486
    • 20197344010483
    • 10197344010479
    • 20197344010476
    • 10197344010462
    • 20197344010469
    Lot code
    All lot codes
    Recall number
    Z-2991-2026
  2. Medline item number
    • HUD78001KIT
    Teleflex item number
    • 780-01KIT
  3. Medline item number
    • HUD78007
    Teleflex item number
    • 780-07
  4. Medline item number
    • HUD78007KIT
    Teleflex item number
    • 780-07KIT
  5. Medline item number
    • HUD78008KIT
    Teleflex item number
    • 780-08KIT
  6. Medline item number
    • HUD78009
    Teleflex item number
    • 780-09
  7. Medline item number
    • HUD78009KIT
    Teleflex item number
    • 780-09KIT
  8. Medline item number
    • HUD78013
    Teleflex item number
    • 780-13
  9. Medline item number
    • HUD78014
    Teleflex item number
    • 780-14
  10. Medline item number
    • HUD78015
    Teleflex item number
    • 780-15
  11. Medline item number
    • HUD78017KIT
    Teleflex item number
    • 780-17KIT
  12. Medline item number
    • HUD78018
    Teleflex item number
    • 780-18
  13. Medline item number
    • HUD78018KIT
    Teleflex item number
    • 780-18KIT
  14. Medline item number
    • HUD78019
    Teleflex item number
    • 780-19
  15. Medline item number
    • HUD88001KIT
    Teleflex item number
    • 880-01KIT
  16. Medline item number
    • HUD88013KIT
    Teleflex item number
    • 880-13KIT
  17. Medline item number
    • HUD88014KIT
    Teleflex item number
    • 880-14KIT
  18. Medline item number
    • HUD88015KIT
    Teleflex item number
    • 880-15KIT
  19. Medline item number
    • HUD88017KIT
    Teleflex item number
    • 880-17KIT

  20. Medline breathing circuits

    UDI-DI
    • 10197344042463
    • 20197344042460
    • 10197344010660
    • 20197344010667
    Lot code
    All Lots manufactured before July 9, 2026 and 26GOA473
    Recall number
    Z-2992-2026

Recall details

Company began the recall
Sold in

Worldwide distribution - US Nationwide and the country of Panama.

Company
Medline Industries, LPNorthfield, Illinois
Hazard
Device defect
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
99403
Recall numbers
Z-2991-2026 to Z-2993-2026

All recalls from Medline Industries, LP

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Announced by the company

  3. Listed on Recall Canary

  4. Added to FDA's Enforcement Report · Classified by FDA

  5. In FDA's weekly enforcement report

  6. Summary updated

More from Medline Industries

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Summary by Recall Canary, written with AI · summary updated Oct 7, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)