Sunmed 1-7333-25Recalls & reported problems
Sunmed, LLC · E/T TUBE CUFFED 2.5mm 10FR · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889483048108), received between Jun 14, 2024 and Apr 11, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Blocked Connection” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jul 31, 2026Open, Classified
The 6Fr suction catheter could not pass through the samples smoothly.
Z-3172-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Blocked Connection2
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.
MalfunctionApr 11, 2026Blocked Connection
IT WAS REPORTED THAT THE 2.5 MM CUFFED ENDOTRACHEAL TUBE (ETT) DID NOT ALLOW PASSAGE OF THE 5/6 FRENCH SUCTION CATHETER. ON (B)(6), 2026, IT WAS FURTHER NOTED THAT THE EVENT WAS ASSOCIATED WITH PATIENT ISSUES REQUIRING EXTUBATION AND REINTUBATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24847322 ↗MalfunctionJun 14, 2024Blocked Connection; Blocked Connection
THE AREA WHERE THE PILOT BALLOON MEETS THE TUBE IS NARROWED, SO MUCH THAT A SUCTION CATHETER CANNOT BE PASSED THROUGH CAUSING SAFETY CONCERNS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19543634 ↗
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 · each recall links to the FDA recall notice
- 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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