HUDSON RCI HUD1007Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10197344011605), received between Sep 1, 2026 and Sep 17, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Loose or Intermittent Connection

  It was reported that "Loose oxygen tubing on mask. The tubing comes off the nipple port of the mask easily."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805008 ↗
• MalfunctionSep 10, 2026Material Twisted/Bent

  It was reported that "Deformed/Leaking" and "The tube has a bend/crease near the joint."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713918 ↗
• MalfunctionSep 8, 2026Detachment of Device or Device Component

  It was reported that "Oxygen tubing falling off the connection point at the mask."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668606 ↗
• MalfunctionSep 1, 2026Material Puncture/Hole; Gas/Air Leak; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50546384 ↗