MEDLINE DYNJAFLEX80Recalls & reported problems

Medline Industries, Inc. · ENDOTRACH TUBE, CUFFED, FLEX, 8.0MM · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10197344104772), received between Jun 9, 2026 and Jul 27, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).

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 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Puncture/Hole1
Unintended Deflation1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 27, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50046753 ↗
MalfunctionJun 9, 2026Unintended Deflation
A SLOW LEAK IN THE PILOT BALLOON HAPPENED IN THE OPERATING ROOM (OR).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25451383 ↗

Device details

UDI-DI	`10197344104772`
Brand	MEDLINE
Model	DYNJAFLEX80
Company	Medline Industries, Inc.
Product code	BTR · Tube, tracheal (w/wo connector)
Class	Class 2
FDA submission	K160694
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 20, 2026

Device type (GMDN): Basic endotracheal tube, single-use

A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

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All Tube, tracheal (w/wo connector) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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