Medline Industries, Inc. DYND43030Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10080196503773), received between Jul 1, 2026 and Jul 1, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

1 other recall cover devices cleared under the same FDA submission (K042683); they may or may not involve this specific model.

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.

• InjuryJul 1, 2026Difficult to Remove; Material Too Rigid or Stiff; Material Integrity Problem

  IT WAS REPORTED BY THE FACILITY THAT, "THE NEONATE WAS INTUBATED ON (B)(6) 2026 WITH A 3.0-CUFFED TUBE (MEDLINE BRAND). COULD NOT BE EXTUBATED IN NICU ON (B)(6) 2026 DUE TO THE FACT THAT THE ETT GOT STUCK IN THE LARYNX. MULTIPLE ATTEMPTS MADE BY RT AND PROVIDERS. THE CUFF WAS DEFLATED AND THE TAPE REMOVED BUT ETT SEEMED STUCK. DETERMINED AIRWAY WAS TOO SWOLLEN TO EXTUBATE AND ETT HAD TO BE RETAPED AND THIS ETT IS TO REMAIN IN PLACE UNTIL AIRWAY SWELLING SUBSIDES. PATIENT STARTED ON DECADRON. ENT CONSULTED. THIS NEONATE UNDERWENT AN ENT AIRWAY EVALUATION AND EXTUBATION IN THE OR AFTER REMOVAL OF ETT ON (B)(6) 2026. IT WAS FOUND THAT THE CUFF OF THIS ETT WAS EXCESSIVELY LARGE AND RIGID, WHICH CONTRIBUTED TO THE PROBLEM. IN ADDITION, AFTER FULL DEFLATION, THIS CUFF HAS LARGE, HARD, PROTRUDING EDGES THAT RESEMBLE THE MERCEDES-BENZ LOGO IN CROSS-SECTION".

  Patient problems: Swelling/ Edema; Upper Respiratory Tract Injury

  MAUDE report 25679414 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042683. One submission often covers many models, so check the product and lot details in each record.

• Z-3172-2026 · Jul 31, 2026 · Open, Classified
  SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25