RUSCH IPN040775Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14026704340795), received between Aug 25, 2022 and Aug 25, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

23 other recalls cover devices cleared under the same FDA submission (K961840); 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.

Recalls naming this device

1. May 25, 2023Open, Classified

   Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

   Z-1874-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionAug 25, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  COMPLAINT REPORTS THAT: "IT IS REPORTED THAT NO MARKS PRINTED IN THE TUBE IS IDENTIFIED FOR ADEQUATE PLACEMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292121 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K961840. One submission often covers many models, so check the product and lot details in each record.

• Z-1856-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506535
• Z-1854-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506525
• Z-1855-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530
• Z-1876-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382050
• Z-1937-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382055
• Z-1859-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550
• Z-1932-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380060
• Z-1934-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382025
• Z-1938-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382060
• Z-1929-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380045
• Z-1875-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382035
• Z-1930-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380050
• Z-1936-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382045
• Z-1925-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380025
• Z-1939-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382065

…and 8 more.