Medline Industries, Inc. DYND43070Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10080196996391), received between Aug 22, 2024 and Nov 24, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 reports).

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

• InjuryNov 24, 2025Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, THE "ETT CUFF FAILURE" WAS NOTED PRIOR TO PREPPING THE PATIENT FOR A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633775 ↗
• InjuryNov 24, 2025Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, THE "ETT CUFF FAILURE" WAS NOTED PRIOR TO PREPPING THE PATIENT FOR A SURGICAL PROCEDURE. PER THE CUSTOMER "THE ETT WAS REMOVED AND REPLACED." THE CUSTOMER SAID THAT "THE CUFF OF THE SECOND ETT WAS NOTED TO HAVE A SIGNIFICANT LEAK" AFTER THE PATIENT WAS PREPPED AND DRAPED. THE CUSTOMER REPORTED THAT "THE ETT WAS AGAIN REPLACED BUT WITH A DIFFERENT [MANUFACTURER'S] ETT" AND THE SURGICAL PROCEDURE WAS "COMPLETED WITHOUT ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632833 ↗
• MalfunctionOct 30, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PIECE OF PLASTIC IN TUBE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20570395 ↗
• MalfunctionAug 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY ON (B)(6) 2024, "ENDOTRACHEAL TUBE BALLOON FAILED TO STAY INFLATED AFTER PATIENT INTUBATION".

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20030337 ↗

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