FDA alerts recall of Medline neonatal heated wire breathing circuits over connector failures

The FDA's Center for Devices and Radiological Health issued an Early Alert to warn the public about a high‑risk issue with Medline's neonatal and infant heated wire breathing circuits. The problem involves failures of the electrical connector on the devices.

Medline has sent a letter to customers recommending that all lots of the Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits be removed from use or sale. The alert lists numerous affected product codes and item numbers for both single‑ and dual‑limb circuits.

The agency says it will continue to monitor the situation and update the web page as significant new information becomes available.