Medline DYNJ18875Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888277652705), received between Jan 3, 2024 and Sep 25, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Pressure Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906098 ↗
• MalfunctionSep 25, 2026Detachment of Device or Device Component

  It was reported that "the entire pilot balloon fell off while the patient was intubated. The cuff did indeed deflate."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902593 ↗
• MalfunctionSep 3, 2026Fitting Problem; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50597776 ↗
• MalfunctionAug 13, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50236532 ↗
• InjuryMay 24, 2024Inflation Problem; Inflation Problem

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 THE PATIENT REQUIRED "INSERTION/PLACEMENT OF ETT" FOR "RESPIRATORY DISTRESS", AND THE CUFF "DID NOT INFLATE TO PROVIDE SECUREMENT IN THE TRACHEA" WHEN "10CC OF AIR" WAS USED TO FILL THE CUFF.

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

  MAUDE report 19392278 ↗
• InjuryJan 3, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY "THE CUFF INFLATION BALLOON LINE FROM THE ETT WAS DISLODGED WHILE STILL IN PATIENT'S THROAT RESULTING IN POOR VENTILATION AND REQUIRED THE PATIENT TO BE RE-INTUBATED".

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

  MAUDE report 18434470 ↗

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