HUDSON RCI HUD1613Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10197344012367), received between Sep 22, 2026 and Sep 22, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Gas/Air Leak

  This summary report covers one malfunction event that Medline became aware of between (b)(6), 2025. This VMSR summarizes one malfunction event involving a Medline unheated adult breathing circuit (catalog number HUD1613). The account reported that the circuit was not passing leak tests at multiple facilities. Evaluation of the returned device confirmed leakage. No patient information was available. No patient or user injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855473 ↗