Stop using now Medical device recall · FDA · Published July 13, 2026

Medline Neonatal Breathing Circuits Risk of Sporadic Failure in Infants

Medline recalls neonatal breathing circuits with potential sporadic failure causing infant respiratory issues. Affected models include HUD78007, HUD78009, and others. Stop using immediately if you have these circuits.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2992-2026Medical device Medline ›

Stop using this now

Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

✎ GovInfoNow plain-language explainer

Medline is recalling neonatal breathing circuits that may fail sporadically, risking infant breathing problems like airway obstruction or respiratory distress. This is serious because the failure can cause life-threatening complications for newborns. Read more at govinfonow.com/recall/697883-medline-neonatal-breathing-circuits-risk-of-sporadic-failure-in-infants.

Source Summary by GovInfoNow · govinfonow.com/recall/697883-medline-neonatal-breathing-circuits-risk-of-sporadic-failure-in-infants · Updated September 23, 2026 · FDA enforcement record: FDA #Z-2992-2026

Cite this page

“Medline Neonatal Breathing Circuits Risk of Sporadic Failure in Infants.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/697883-medline-neonatal-breathing-circuits-risk-of-sporadic-failure-in-infants. Based on FDA recall #Z-2992-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2992-2026%22&limit=1).

The FDA announced on July 13, 2026, that Medline Industries, LP is recalling neonatal and infant heated wire breathing circuits due to a risk of thermal damage. The agency said the failure may cause airway obstruction or worsening respiratory distress in infants.

How to tell if you have it

HUD78007 (Teleflex SKU 780-07)
HUD78009 (Teleflex SKU 780-09)
780-13 (Teleflex SKU 780-13)
780-14 (Teleflex SKU 780-14)
780-15 (Teleflex SKU 780-15)
HUD78018 (Teleflex SKU 780-18)

The hazard

GovInfoNow's records show the FDA stated the heated wire connector may exhibit discoloration, melting, smoke, or a burning odor. The agency said device failure may predispose infants to bronchospasm, inspissated secretions, airway obstruction, inadvertent positive end-expiratory pressure, circuit obstruction, accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

Context

GovInfoNow's records show Medline Industries, LP has had 68 other recalls on record since July 31, 2025. Other recent recalls include Medline Basic Homecare Beds (Aug. 14, 2026), Medline Convenience Kits with fungal contamination risk (Aug. 11, 2026), and Medline convenience kits with Healthmark Instrument Channel Brushes (Aug. 10, 2026). Other recent recalls of similar products include Hamilton Medical Breathing Circuit Sets (May 29, 2026), CooperSurgical Neonatal CPAP Replacement Set (Aug. 11, 2026), and ICU Medical Hotline Fluid Warming Set (June 24, 2026).

How to tell if you have this one

Check for the model labels: HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48 (HUD78007), or similar combinations with Medline Product Numbers like HUD78009, 780-13, 780-14, 780-15, or HUD78018. These were sold with specific lot numbers and dates.

Brand
Medline
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the country of Panama.

Recall number	Product, codes & lots	Quantity
Z-2991-2026	Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit. Respiratory gas humidifier.; All lot codes	20 units
Z-2992-2026	Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON RCI, DBM-CIRCUIT,VENT,NEONATAL,21 V, Medline Product Number/SKU HUD78009 (Teleflex Product Number/SKU 780-09); 3) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-13 (Teleflex Product Number/SKU 780-13); 4) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-14 (Teleflex Product Number/SKU 780-14); 5) HUDSON RCI, DBD-CIRCUIT, HTD, DUAL LIMB, NEONATE, Medline Product Number/SKU 780-15 (Teleflex Product Number/SKU 780-15); 6) HUDSON RCI, CIRCUIT,NEO,DUAL,WIRE,60 IN, Medline Product Number/SKU HUD78018) (Teleflex Product Number/SKU 780-18).; 1) Medline Product Number/SKU HUD78007, UDI/DI 10197344042463 (each) 20197344042460 (case), All lot numbers; 2) Medline Product Number/SKU HUD78009, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 3) Medline Product Number/SKU 780-13, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 4) Medline Product Number/SKU 780-14, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 5) Medline Product Number/SKU 780-15, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 6) Medline Product Number/SKU HUD78018, UDI/DI 10197344010660 (each) 20197344010667 (case), All lot numbers.	145525 units
Z-2993-2026	Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78001KIT (Teleflex Product Number/SKU 780-01KIT); 2) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78007KIT (Teleflex Product Number/SKU 780-07KIT); 3) MEDLINE HUDSON RCI, DBD-CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78008KIT (Teleflex Product Number/SKU 780-08KIT); 4) MEDLINE HUDSON RCI, DBD-CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78009KIT (Teleflex Product Number/SKU 790-09KIT); 5) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78017KIT (Teleflex Product Number/SKU 780-17KIT); 6) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL HTD, DUAL LIMB,COLUMN, Medline Product Number/SKU HUD78018KIT (Teleflex Product Number/SKU 780-18KIT); 7) MEDLINE HUDSON RCI, CIRCUIT,ISO-SHIELD SINGLE LIMB,INFANT, Medline Product Number/SKU HUD88001KIT (Teleflex Product Number/SKU 880-01KIT); 8) MEDLINE HUDSON RCI, CIRCUIT,ISO-SHIELD,INFANT,HTD,COLUMN,DRN, Medline Product Number/SKU HUD88013KIT (Teleflex Product Number/SKU 880-13KIT); 9) MEDLINE HUDSON RCI, ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88014KIT (Teleflex Product Number/SKU 880-14KIT); 10) MEDLINE HUDSON RCI,ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88015KIT (Teleflex Product Number/SKU 880-15KIT); 11) MEDLINE HUDSON RCI, ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88017KIT (Teleflex Product Number/SKU 880-17KIT).; 1) Medline Product Number/SKU HUD78001KIT (Teleflex Product Number/SKU 780-01KIT), UDI/DI 10197344010752 (each) 20197344010759 (case), All lot numbers; 2) Medline Product Number/SKU HUD78007KIT (Teleflex Product Number/SKU 780-07KIT), UDI/DI 10197344010738 (each) 20197344010735 (case), All lot numbers; 3) Medline Product Number/SKU HUD78008KIT (Teleflex Product Number/SKU 780-08KIT), UDI/DI 10197344010721 (each) 20197344010728 (case), All lot numbers; 4) Medline Product Number/SKU HUD78009KIT (Teleflex Product Number/SKU 790-09KIT), UDI/DI 10197344010714 (each) 20197344010711 (case), All lot numbers; 5) Medline Product Number/SKU HUD78017KIT (Teleflex Product Number/SKU 780-17KIT), UDI/DI 10197344010677 (each) 20197344010674 (case), All lot numbers; 6) Medline Product Number/SKU HUD78018KIT (Teleflex Product Number/SKU 780-18KIT), UDI/DI 10197344010905 (each) 20197344010902 (case), All lot numbers; 7) Medline Product Number/SKU HUD88001KIT (Teleflex Product Number/SKU 880-01KIT), UDI/DI 10197344010929 (each) 20197344010926 (case), All lot numbers; 8) Medline Product Number/SKU HUD88013KIT (Teleflex Product Number/SKU 880-13KIT), UDI/DI 10197344010493 (each) 20197344010490 (case), All lot numbers; 9) Medline Product Number/SKU HUD88014KIT (Teleflex Product Number/SKU 880-14KIT), UDI/DI 10197344010486 (each) 20197344010483 (case), All lot numbers; 10) Medline Product Number/SKU HUD88015KIT (Teleflex Product Number/SKU 880-15KIT), UDI/DI 10197344010479 (each) 20197344010476 (case), All lot numbers; 11) Medline Product Number/SKU HUD88017KIT (Teleflex Product Number/SKU 880-17KIT), UDI/DI 10197344010462 (each) 20197344010469 (case), All lot numbers;	271406 units

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discontinue use of the affected breathing circuits as they may fail and cause serious harm to infants.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the country of Panama.” 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 51 days after the firm started it.

Jul 13, 2026Firm started the recall
Aug 21, 2026FDA classified it Class II
Sep 2, 2026Published in FDA’s Enforcement Report
Sep 8, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/697883-medline-neonatal-breathing-circuits-risk-of-sporadic-failure-in-infants">Medline Neonatal Breathing Circuits Risk of Sporadic Failure in Infants (GovInfoNow)</a>

Where this comes from

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-2992-2026 (July 13, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2992-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 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.