RUSCH IPN915474Recalls & reported problems
Teleflex Incorporated · RUSCH TRULITE SECURE SU BLADE-HANDLE MILL 0 · Class 1
Data updated Oct 13, 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 14026704711540), received between May 27, 2026 and May 27, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Sharp Edges” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Sharp Edges1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Sharp Edges
IT WAS REPORTED THAT "BLADE SIZE 0 IS LARGER IN DIAMETER THAN EXPECTED, THE END/TIP OF THE BLADE IS WIDER AND SHARP. THE BLADE DESIGN DOES NOT ACCURATELY MATCH THE STANDARD MILLER BLADE PROFILE. AN OVA HAS BEEN RAISED AFTER A FAILED INTUBATION CASE (TWO UNSUCCESSFUL ATTEMPTS), RESULTING IN PATIENT COMPROMISE." ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2026, INDICATED THAT "NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT, PATIENT'S CURRENT CONDITION IS GOOD. NO MEDICAL INTERVENTION REQUIRED. A VERY SHARP EDGE OF THE LARYNGOSCOPE IS OBSERVED, AND THE END-USERS BELIEVE THAT THE FAILED INTUBATION IS BECAUSE OF THE SHARP BACK EDGE OF THE LARYNGOSCOPE AND DIMENSIONAL DIFFERENCES. BOTH FAILED INTUBATION ATTEMPTS WERE ON THE SAME PATIENT. THE REPORTED DESIGN AND DIMENSIONAL DIFFERENCES WERE IDENTIFIED AFTER INTUBATION FAILURE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25311068 ↗
Other LARYNGOSCOPE, RIGID devices
- McGRATH MAC 301-000-000Covidien LP · LARYNGOSCOPE, RIGID2 recalls202 reports
- McGRATH MAC 300-000-000Covidien LP · LARYNGOSCOPE, RIGID1 recall1 death205 reports
- n.a. 8404HXKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID242 reports
- McGRATH 340-000-000Covidien LP · LARYNGOSCOPE, RIGID2 deaths192 reports
- McGRATH MAC 301-000-000Covidien LP · LARYNGOSCOPE, RIGID2 recalls90 reports
- n.a. 8404BXCKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID141 reports
- n/a 8404AXCKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID108 reports
- McGRATH 340-000-000Covidien LP · LARYNGOSCOPE, RIGID84 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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