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RUSCH IPN044696Recalls & reported problems

Teleflex Incorporated · FLEXI-SET UNCUFFED STERILE · Class 2

Data updated Oct 13, 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
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

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

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. 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-1858-2023 · Root cause: Under Investigation by firm · FDA record ↗

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-1875-2023 · May 25, 2023 · Open, Classified
    Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382035
  • Z-1935-2023 · May 25, 2023 · Open, Classified
    Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382040
  • Z-1854-2023 · May 25, 2023 · Open, Classified
    Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506525
  • Z-1938-2023 · May 25, 2023 · Open, Classified
    Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382060
  • Z-1859-2023 · May 25, 2023 · Open, Classified
    Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550
  • Z-1855-2023 · May 25, 2023 · Open, Classified
    Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530
  • Z-1928-2023 · May 25, 2023 · Open, Classified
    Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380040
  • Z-1931-2023 · May 25, 2023 · Open, Classified
    Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380055
  • Z-1937-2023 · May 25, 2023 · Open, Classified
    Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382055
  • Z-1925-2023 · May 25, 2023 · Open, Classified
    Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380025
  • Z-1926-2023 · May 25, 2023 · Open, Classified
    Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380030
  • Z-1936-2023 · May 25, 2023 · Open, Classified
    Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382045
  • Z-1929-2023 · May 25, 2023 · Open, Classified
    Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380045
  • Z-1930-2023 · May 25, 2023 · Open, Classified
    Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380050
  • Z-1857-2023 · May 25, 2023 · Open, Classified
    Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506540

…and 8 more.

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