Shiley 109875Recalls & reported problems
Covidien LP · Oral/Nasal Tracheal Tube Seal Guard, Murphy Eye · Class 2
All models of Shiley (387)
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 10884521211780), received between Dec 28, 2023 and Dec 28, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K082520); 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Labelling, Instructions for Use or Training Problem2
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.
MalfunctionDec 28, 2023Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
ACCORDING TO THE REPORTER, THE INTUBATION PROBE MARKER DIGITS OF THE ENDOTRACHEAL TUBE FADE VERY QUICKLY. THE TUBE KEPT IN USE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18414694 ↗MalfunctionDec 28, 2023Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
ACCORDING TO THE REPORTER, THE INTUBATION PROBE MARKER DIGITS OF THE ENDOTRACHEAL TUBE FADE VERY QUICKLY. THE TUBE KEPT IN USE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18413470 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K082520. One submission often covers many models, so check the product and lot details in each record.
- Z-1626-2016 · Apr 4, 2016 · TerminatedLauncher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..
- Z-1625-2016 · Apr 4, 2016 · TerminatedMallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175
Other Tube, tracheal (w/wo connector) devices
- Shiley 18875Covidien LP · Tube, tracheal (w/wo connector)4 deaths570 reports
- RUSCH IPN041476Teleflex Incorporated · Tube, tracheal (w/wo connector)10 recalls0 reports
- Shiley 18775Covidien LP · Tube, tracheal (w/wo connector)489 reports
- Shiley 18770Covidien LP · Tube, tracheal (w/wo connector)2 deaths434 reports
- Shiley 18880Covidien LP · Tube, tracheal (w/wo connector)2 deaths370 reports
- Shiley 18780Covidien LP · Tube, tracheal (w/wo connector)3 deaths286 reports
- Shiley 18770SCovidien LP · Tube, tracheal (w/wo connector)273 reports
- Shiley 18780SCovidien LP · Tube, tracheal (w/wo connector)251 reports
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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