Medline Industries, Inc. DYND40972Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10080196033317), received between Aug 13, 2026 and Sep 14, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 24, 2025Class IIOpen, Classified

   A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.

   Z-1312-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Material Twisted/Bent

  Patient problems: Discomfort

  MAUDE report 50763618 ↗
• MalfunctionAug 17, 2026Break

  It was reported that "the suction Cath 14fr are defective and keep breaking on them" and "they keep falling apart when using them, and that it has been going on for months now.."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50275605 ↗
• MalfunctionAug 13, 2026Suction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50239313 ↗