Medline DYNJ18870Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888277652699), received between Dec 29, 2023 and Sep 9, 2026 — classified as 2 injuries, 2 malfunctions.

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

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

1 other recall cover devices cleared under the same FDA submission (K110269); 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.

Recalls naming this device

1. Feb 26, 2024Class IOpen, Classified

   Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult to connect or detaches during use.

   Z-1876-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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 9, 2026Material Separation

  Patient problems: Insufficient Information

  MAUDE report 50696603 ↗
• MalfunctionAug 13, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50236853 ↗
• InjuryDec 29, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY ON (B)(6) 2023 THE PATIENT REQUIRED REINTUBATION DUE TO A LEAK IN THE CUFF BALLOON AS THERE WAS "NOTICED MOISTURE IN THE BALLOON".

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

  MAUDE report 18421906 ↗
• InjuryDec 29, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY ON 12/04/23 THE PATIENT REQUIRED REINTUBATION DUE TO A LEAK IN THE CUFF BALLOON AS THERE WAS "NOTICED MOISTURE IN THE BALLOON".

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

  MAUDE report 18421288 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110269. One submission often covers many models, so check the product and lot details in each record.

• Z-2243-2016 · Jun 2, 2016 · Terminated
  Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is use