Stylet, Tracheal Tube
Anesthesiology · 21 CFR 868.5790
Recent MDR events
506 adverse event reports on file
- GLIDERITE SINGLE-USE STYLET - SMALLJun 16, 2026InjuryVerathon Medical Ulc9615393-2026-00084
- VITAL SIGNSApr 14, 2026MalfunctionVyaire Medical Inc.1314417-2026-00024
- GLIDERITE RIGID STYLETFeb 18, 2026InjuryVerathon Medical Ulc9615393-2026-00021
- GLIDERITE SINGLE-USE STYLET - SMALLFeb 10, 2026InjuryVerathon Medical Ulc9615393-2026-00015
- AINTREE INTUBATION CATHETERFeb 6, 2026MalfunctionCook Inc1820334-2026-00129
- COOK STAGED EXTUBATION SETDec 3, 2025MalfunctionCook Inc1820334-2025-01494
- 6FR,STYLET,ET TUBEOct 31, 2025InjuryMedline Industries, Lp1417592-2025-00590
- GLIDERITE SINGLE-USE STYLET - SMALLOct 7, 2025MalfunctionVerathon Medical Ulc9615393-2025-00112
- RUSCH TRACHEAL TUBE, CUFFED, NASAL PREFORMEDJul 28, 2025MalfunctionTeleflex Medical Sdn. Bhd.8040412-2025-00186
- SHILEYApr 24, 2025MalfunctionCovidien Ag Juarez (mmj)9681384-2025-00422
Event type breakdown
Recalls
16 recall events for this product code
- Smiths Medical ASD, Inc.Open, ClassifiedNov 25, 2024
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
Z-0527-2025 · View FDA record ↗ - Smiths Medical ASD, Inc.Open, ClassifiedNov 25, 2024
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
Z-0528-2025 · View FDA record ↗ - Smiths Medical ASD, Inc.Open, ClassifiedNov 25, 2024
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
Z-0529-2025 · View FDA record ↗ - Brathwaites Oliver MedicalTerminatedOct 11, 2016
The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthe
The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.
Z-0067-2017 · View FDA record ↗ - Teleflex MedicalTerminatedNov 6, 2015
Rsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.
Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
Z-0245-2016 · View FDA record ↗ - Teleflex MedicalTerminatedNov 6, 2015
Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.
Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
Z-0246-2016 · View FDA record ↗ - Vital Signs Colorado Inc.TerminatedApr 30, 2015
CareFusion Vital Signs LightWand Stylet.
Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.
Z-1556-2015 · View FDA record ↗ - Vital Signs Colorado Inc.TerminatedApr 30, 2015
Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.
Z-1557-2015 · View FDA record ↗ - Cardinal HealthTerminatedFeb 4, 2015
Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency faci
A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube.
Z-1054-2015 · View FDA record ↗ - Teleflex MedicalTerminatedJan 11, 2012
Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog numbers: 502501, Teleflex Medical Sdn Bhd, P.O. Box, Industrial Estate, 24600 Kamun
Complaints of difficulty removing stylet from the endotracheal tube and possible PVC sheath separation were received.
Z-0517-2012 · View FDA record ↗
Registered firms
139 firms currently registered for this product code
Worldwide Supplies Limited
Hong Kong, HK
Modern Medical Equipment Manufacturing, Ltd.
KWAI CHUNG, N.T., HK
Khtp Sterilisation Services Sdn. Bhd.
Kulim Hi Tech Park Kedah, MY
Cook Incorporated
Spencer, IN, US
Ad Supply Group Limited
London London, City of, GB
Mcreat ( Guangzhou ) Bio-tech Co.,ltd
Guangzhou Guangdong, CN
Forefront Medical Technology (jiangsu) Co.,ltd
Changzhou Jiangsu, CN
Sterilization Services Of Georgia, Inc.
ATLANTA, GA, US
Modern Medical Equipment Manufacturing Ltd.
HENG LI, DONGGUAN Guangdong, CN
Hangzhou Jinlin Medical Appliances Co., Ltd.
Hangzhou Zhejiang, CN
Nevap Inc Inventory Management
San Jose, CA, US
Anamed, Llc
Charlotte, NC, US
Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd.
Shuyang Jiangsu, CN
Verathon Medical (canada) Ulc.
BURNABY British Columbia, CA
Truer Medical, Inc.
ORANGE, CA, US
Modern Medical Equipment Manufacturing (qing Yuan) Ltd
QING YUAN Guangdong, CN
Icu Medical Healthcare Manufacturing S.a. De C.v.
APODACA Nuevo Leon, MX
Hangzhou Shanyou Medical Equipment Co.,ltd
Hangzhou Zhejiang, CN
Intersurgical Ltd.
WOKINGHAM, BERKSHIRE, GB
Sterigenics Us Llc
Grand Prairie, TX, US
Principle & Will Biotech (pinghu) Co., Ltd.
Pinghu City Zhejiang, CN
Sterigenics Us Llc
Gurnee, IL, US
Hospital & Homecare Imp. & Exp. Co., Ltd
NANJING Jiangsu, CN
Anestek Corp.
Taoyuan City, TW
Covidien
- Santo Domingo, DO
510(k) clearances
32 clearances for this product code
- Cook IncorporatedAug 11, 2017
K162729 · Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
- Laerdal Medical Corp.Sep 5, 1996
K962361 · TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND
- Laerdal Medical Corp.May 9, 1996
K954771 · TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
- Molloy Corp.Apr 18, 1996
K943104 · MOLLOY INTUBATING STYLETTE
- Rusch Intl.Feb 6, 1996
K955238 · RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
- Scientific Sales Intl., Inc.Aug 25, 1995
K953677 · LIGHTED FLEXGUIDE (MODIFICATION)
- Rusch, Inc.Aug 8, 1995
K952100 · RUSCH ENDOTRACHEAL TUBE STYLET
- Stebar Instrument Corp.Jun 12, 1995
K952266 · SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE