Skip to content

Sunmed 1-7333-30Recalls & reported problems

Sunmed, LLC · E/T TUBE CUFFED 3.0mm 12FR · Class 2

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889483040508), received between Apr 19, 2023 and Apr 19, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

1 other recall cover devices cleared under the same FDA submission (K042683); 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.

Most reported problems

Device problems

  • Deformation Due to Compressive Stress1

Patient problems

  • Respiratory Insufficiency1

Recent adverse event reports

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

  • InjuryApr 19, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

    CLINICIAN FELT A "POPPING" AS THE CUFF WAS BEING REMOVED. THE PATIENT NEEDED RACEMIC EPI FOR STRIDOR LATER IN THE DAY.

    Patient problems: Respiratory Insufficiency

    MAUDE report 16773055 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042683. One submission often covers many models, so check the product and lot details in each record.

  • Z-3172-2026 · Jul 31, 2026 · Open, Classified
    SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25

Other Tube, Tracheal (W/Wo Connector) devices

All Tube, Tracheal (W/Wo Connector) devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page