Device, Fixation, Tracheal Tube
FDA adverse event reports and recall history for device, fixation, tracheal tube (product code CBH), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 819
- Deaths
- 21
- Injuries
- 363
- Malfunctions
- 343
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-02-19Open, ClassifiedProcess change control
AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
- 2025-02-19Open, ClassifiedProcess change control
AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
- 2025-02-19Open, ClassifiedProcess change control
AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
- 2025-02-19Open, ClassifiedProcess change control
AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
- 2024-12-18Open, ClassifiedNonconforming Material/Component
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
- 2024-12-18Open, ClassifiedNonconforming Material/Component
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
- 2024-12-18Open, ClassifiedNonconforming Material/Component
HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
- 2024-12-18Open, ClassifiedNonconforming Material/Component
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
- 2008-01-11TerminatedLabeling design
Dale 240 Blue (Adults) Tracheostomy Tube Holder, Product Number: H84102401, Dale Medical Products, Inc., Plainville, MA 02762
Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to disengage at the trach plate
- 2008-01-11TerminatedLabeling design
Dale 242 Blue (Neonate, Infants and Small Children) Tracheostomy Tube Holder, Product Number: H84102421, Dale Medical Products, Inc., Plainville, MA 02762
Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to disengage at the trach plate
Monitor device, fixation, tracheal tube automatically
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