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
- 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, ClassifiedEndotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382035
- Z-1935-2023 · May 25, 2023 · Open, ClassifiedEndotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382040
- Z-1854-2023 · May 25, 2023 · Open, ClassifiedFlexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506525
- Z-1938-2023 · May 25, 2023 · Open, ClassifiedEndotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382060
- Z-1859-2023 · May 25, 2023 · Open, ClassifiedFlexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550
- Z-1855-2023 · May 25, 2023 · Open, ClassifiedFlexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530
- Z-1928-2023 · May 25, 2023 · Open, ClassifiedEndotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380040
- Z-1931-2023 · May 25, 2023 · Open, ClassifiedEndotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380055
- Z-1937-2023 · May 25, 2023 · Open, ClassifiedEndotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382055
- Z-1925-2023 · May 25, 2023 · Open, ClassifiedEndotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380025
- Z-1926-2023 · May 25, 2023 · Open, ClassifiedEndotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380030
- Z-1936-2023 · May 25, 2023 · Open, ClassifiedEndotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382045
- Z-1929-2023 · May 25, 2023 · Open, ClassifiedEndotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380045
- Z-1930-2023 · May 25, 2023 · Open, ClassifiedEndotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380050
- Z-1857-2023 · May 25, 2023 · Open, ClassifiedFlexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506540
…and 8 more.
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 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- 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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