FDA Recalls medium

Hudson RCI Neonatal Breathing Circuits Recall

Source: FDA · United States and Panama

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Medline Industries, LP is recalling 145,525 units of Hudson RCI neonatal and infant heated wire breathing circuits due to potential connector failure.

FDA recall: what the record actually shows

This notice was issued by FDA on September 8, 2026 and geographically references United States and Panama. The FDA classifies this as a Class II recall, with the stated reason "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.", distributed worldwide distribution - us nationwide and the country of panama.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

A quick skim tells you whether this affects you directly; a closer read tells you more. Check the scope, the source, and how recent the record is, then weigh it against related notices rather than treating any single one as a trend.

The original agency source is linked below so you can verify this record directly before acting on it. Its related labels are recall, product-safety, fda, medical-devices.

What Happened

Medline Industries, LP initiated a voluntary recall of certain Hudson RCI neonatal and infant heated wire breathing circuits after reports of 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.

Which Products Are Affected

The recall covers 145,525 units distributed worldwide, including US Nationwide and Panama. Affected products include:

  1. HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); UDI/DI 10197344042463 (each) 20197344042460 (case), All lot numbers.
  2. HUDSON RCI, DBM-CIRCUIT,VENT,NEONATAL,21 V, Medline Product Number/SKU HUD78009 (Teleflex Product Number/SKU 780-09); UDI/DI Discontinued (each) Discontinued (case), All lot numbers.
  3. HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-13 (Teleflex Product Number/SKU 780-13); UDI/DI Discontinued (each) Discontinued (case), All lot numbers.
  4. HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-14 (Teleflex Product Number/SKU 780-14); UDI/DI Discontinued (each) Discontinued (case), All lot numbers.
  5. HUDSON RCI, DBD-CIRCUIT, HTD, DUAL LIMB, NEONATE, Medline Product Number/SKU 780-15 (Teleflex Product Number/SKU 780-15); UDI/DI Discontinued (each) Discontinued (case), All lot numbers.
  6. HUDSON RCI, CIRCUIT,NEO,DUAL,WIRE,60 IN, Medline Product Number/SKU HUD78018 (Teleflex Product Number/SKU 780-18); UDI/DI 10197344010660 (each) 20197344010667 (case), All lot numbers. Recall number Z-2992-2026. Classification: Class II. Recall initiation date: 20260713.

What You Should Do

Consumers and healthcare facilities should follow instructions provided by Medline Industries, LP regarding the recalled devices.

Why This Matters

The potential device failures pose risks of serious respiratory complications in neonates and infants.

Source

FDA recall number Z-2992-2026; Medline Industries, LP, Northfield, IL.

Original source: FDA Official Notice ↗

Related FDA Recalls

All FDA Recalls →

Medline Convenience Kits Recall Over ChloraPrep Applicator Sterility Breach (Ref. 2fe0d4)

FDA · September 16, 2026

Cardinal Health Presource Packs Recall Over CliniClean Pericare Wipes Contamination (Ref. 1adab6)

FDA · September 16, 2026

Medline Convenience Kits Recall Over BD ChloraPrep Applicator Seal Issue (Ref. 929d71)

FDA · September 16, 2026

Comparable nationwide notices (length or severity timing) 8

Beyond this FDA recall's own category, Areazine surfaces two nationwide peer sets: length-matched and severity/date-matched notices from elsewhere in the archive, distinct from the same-feed Related list above.

Similar body length

Nearest notices by article body length (2,373 characters here).

Moderate Flood Warning Issued for Upper Brisbane River and Stanley River Catchments 2,373 chars Major Flood Warning Issued for Burnett, Stuart, and Boyne Rivers in Queensland 2,375 chars Dexamethasone Sodium Phosphate Injection Shortage: Current Availability and Manufacturer Updates 2,375 chars Dextrose Monohydrate 70% Injection Shortage: Current Availability and Manufacturer Status 2,371 chars

Similar severity timing

Same severity (medium) notices issued closest in time to September 8, 2026.

Philips Ingenia, Achieva and Intera MR Systems Recall medium Ford Transit Recall Over Rear Seat Belt Buckle Malfunction medium Yellow Severe Thunderstorm Warning in Effect for Big Trout Lake - Kasabonika medium Yellow Watch for Severe Thunderstorm in Effect for Sachigo Lake - Bearskin Lake medium

Frequently Asked Questions

What people usually ask about a notice like this one.

What is this FDA recall about? ▾
Medline Industries, LP is recalling 145,525 units of Hudson RCI neonatal and infant heated wire breathing circuits due to potential connector failure.
Which agency issued this alert? ▾
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How is this recall classified, and why does that matter? ▾
The FDA classifies this as a Class II recall, citing "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." as the reason. Class I is the most serious (reasonable probability of serious harm), Class II is a moderate or temporary health risk, and Class III is unlikely to cause harm.
What area is affected? ▾
This alert affects United States and Panama. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates? ▾
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.

Where this data comes from

EPA Outdoor Air Quality Data

Federal monitoring network, every measurement we report

AirNow (EPA / NOAA)

Real-time AQI for every monitored U.S. location

National Weather Service

Active watches, warnings, and advisories, NOAA

CDC Air Quality & Health

Health-impact reference behind every AQI category