Shiley 86239Recalls & reported problems

Covidien LP · Oral/Nasal Tracheal Tube Cuffless Non DEHP, Murphy Eye · Class 2

All models of Shiley (387)

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521797314), received between May 7, 2026 and May 7, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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

Connection Problem1

Patient problems

Unintended Extubation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 7, 2026Connection Problem
IT WAS REPORTED THAT INTRA-OPERATIVELY, THE 15 MM CONNECTOR OF THE ENDOTRACHEAL TUBE WAS EASY TO LOSE. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 25112172 ↗

Device details

UDI-DI	`10884521797314`
Brand	Shiley
Model	86239
Company	Covidien LP
Product code	BTR · Tube, tracheal (w/wo connector)
Class	Class 2
FDA submission	K151381
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Apr 9, 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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Shiley 18775
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Shiley 18770
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Shiley 18880
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Shiley 18780
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3 deaths286 reports
Shiley 18770S
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Shiley 18780S
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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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