RUSCH IPN041499Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

34 other recalls cover devices cleared under the same FDA submission (K961837); 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. How this data works · Data updated Oct 13, 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-1885-2023 · Root cause: Under Investigation by firm · FDA record ↗

2. Dec 8, 2022Open, Classified

   Potential for pilot balloon non-inflation or cuff non-deflation.

   Z-1011-2023 · Root cause: Process control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K961837. One submission often covers many models, so check the product and lot details in each record.

• Z-1958-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080050
• Z-1962-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080075
• Z-1850-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504575
• Z-1882-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095
• Z-1893-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082095
• Z-1853-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590
• Z-1964-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080085
• Z-1848-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565
• Z-1849-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570
• Z-1851-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504580
• Z-1894-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100
• Z-1959-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060
• Z-1890-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080
• Z-1887-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065
• Z-1886-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082060

…and 19 more.