Tube, Tracheal (w/wo Connector)
Anesthesiology · 21 CFR 868.5730
Recent MDR events
19,095 adverse event reports on file
- ShileyJul 31, 2026MalfunctionCovidien Ag Juarez (mmj)9681384-2026-00768
- ShileyJul 31, 2026MalfunctionCovidien Ag Juarez (mmj)9681384-2026-00769
- ShileyJul 31, 2026MalfunctionCovidien Ag Juarez (mmj)9681384-2026-00770
- SHILEYJul 31, 2026MalfunctionCovidien Ag Juarez (mmj)9681384-2026-00771
- SHILEYJul 31, 2026MalfunctionCovidien Ag Juarez (mmj)9681384-2026-00772
- ShileyJul 31, 2026MalfunctionCovidien Ag Juarez (mmj)9681384-2026-00773
- TaperGuardJul 31, 2026MalfunctionCovidien Ag Juarez (mmj)9681384-2026-00774
- SHERIDAN ET TUBE,CF,7.5Jul 31, 2026MalfunctionTeleflex Medical3003898360-2026-00346
- SHERIDAN ET TUBE,CF,7.5Jul 31, 2026MalfunctionTeleflex Medical3003898360-2026-00349
- ShileyJul 31, 2026MalfunctionCovidien Ag Juarez (mmj)9681384-2026-00777
Event type breakdown
Recalls
226 recall events for this product code
- Smiths Medical ASD, Inc.Open, ClassifiedMar 12, 2025
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100
Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.
Z-1289-2025 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedMay 28, 2024
Medline Sub-G Endotracheal Tube with Subglottic Suctioning:
Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult to connect or detaches during use.
Z-1876-2024 · View FDA record ↗ - TELEFLEX LLCOpen, ClassifiedJun 29, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Z-1827-2023 · View FDA record ↗ - TELEFLEX LLCOpen, ClassifiedJun 29, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Z-1828-2023 · View FDA record ↗ - TELEFLEX LLCOpen, ClassifiedJun 29, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Z-1829-2023 · View FDA record ↗ - TELEFLEX LLCOpen, ClassifiedJun 29, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Z-1830-2023 · View FDA record ↗ - TELEFLEX LLCOpen, ClassifiedJun 29, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170070
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Z-1831-2023 · View FDA record ↗ - TELEFLEX LLCOpen, ClassifiedJun 29, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170075
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Z-1832-2023 · View FDA record ↗ - TELEFLEX LLCOpen, ClassifiedJun 29, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170080
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Z-1833-2023 · View FDA record ↗ - TELEFLEX LLCOpen, ClassifiedJun 29, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Z-1834-2023 · View FDA record ↗
Registered firms
356 firms currently registered for this product code
Synergy Health Ireland Ltd
Tullamore Offaly, IE
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Convatec, Inc.
Greensboro, NC, US
Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi
Cankaya Ankara, TR
Asia Connection Co., Ltd.
New Taipei City, TW
Covidien
Lafayette, CO, US
Teleflex Medical Llc
Morrisville, NC, US
Rhenus Se & Co. Kg
Holzwickede North Rhine-Westphalia, DE
Cook Incorporated
Spencer, IN, US
Productos Urologos De Mexico S.a. De C.v.
MEXICALI Baja California, MX
Khtp Sterilisation Services Sdn. Bhd.
Kulim Hi Tech Park Kedah, MY
Vygon Colombia S.a.
BARRANQUILLA Atlantico, CO
Flexicare Medical (dongguan) Ltd.
DONGGUAN CITY Guangdong, CN
Teleflex Medical Sdn. Bhd.
KAMUNTING Perak, MY
Bd Medical Development
Crown Point, IN, US
Teleflex Medical De Tecate, S. De R.l De C.v.
TECATE Baja California, MX
Medtronic B.v. (eoc)
HEERLEN Limburg, NL
Well Lead Medical Co. Ltd
GUANGZHOU Guangdong, CN
510(k) clearances
241 clearances for this product code
- Spiro RoboticsJun 12, 2026
K253437 · Spiro-VISTA
- Covidien, LLCOct 6, 2025
K250173 · Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR)
- Covidien, LLCSep 25, 2025
K243785 · Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced
- Pipeline Medical Products, LLCAug 13, 2025
K243579 · AeroJet Ventilation Catheter
- William Cook Europe ApsJun 11, 2025
K251499 · Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)
- Flexicare Medical Limited.May 20, 2025
K250243 · ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)
- Teleflex MedicalApr 29, 2025
K242495 · LMA Fastrach ETT SU
- Teleflex IncorporatedFeb 11, 2025
K241451 · Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)