PV Bulletin

Breathing Circuit Recall: Medline Removes Neonatal and Infant Heated Wire Breathing Circuits

Medline is recalling certain neonatal and infant heated wire breathing circuits due to failures involving the electrical connector, classified as a Class II recall.

Primary source: What is an Early Alert?

PV Impact Brief

Urgency: HighConfidence: high

What changed

The FDA has classified this issue as a Class II Recall, impacting specific product lots of Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits, which Medline must now remove from sale or use.

Why it matters

This recall addresses a safety risk associated with the electrical connectors of the breathing circuits that could potentially lead to health complications for patients, especially vulnerable populations like neonates and infants.

Action needed

Healthcare providers and distributors must immediately identify and quarantine affected products before destroying them after completing the recall actions. Compliance with FDA recall procedures is mandatory.

Relevant for
Regulatory Intelligence Lead
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Sep 1, 2026

Full briefing

Practical implication

Healthcare providers and distributors must immediately identify and quarantine affected products before destroying them after completing the recall actions. Compliance with FDA recall procedures is mandatory.

Medline has issued a recall for specific neonatal and infant heated wire breathing circuits due to potential failures with the electrical connector that may lead to temporary or reversible health problems. Affected products must be removed from use or sale, and there are specific actions outlined for healthcare providers and distributors.

What changed: The FDA has classified this issue as a Class II Recall, impacting specific product lots of Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits, which Medline must now remove from sale or use.

Why it matters: This recall addresses a safety risk associated with the electrical connectors of the breathing circuits that could potentially lead to health complications for patients, especially vulnerable populations like neonates and infants.

Practical implication: Healthcare providers and distributors must immediately identify and quarantine affected products before destroying them after completing the recall actions. Compliance with FDA recall procedures is mandatory.

View original source

  • Source: FDA - MedWatch Safety Alerts RSS
  • Published at source: 2026-09-01T00:00:00.000Z
  • Discovered by monitor: 2026-09-01T21:41:45.402Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signal#Safety Signals#Source-ingestion#Regulator-monitor#Usa#Fda.gov

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