The Recall Desk
HighFDA (Devices)·Z-0695-2025·Announced 2024-12-25

HUDSON RCI mBrace ET Tube Holder Risks Facial Dermal Injury

Medline is recalling the HUDSON RCI mBrace ET tube holder because defective adhesive and frame elements may cause pressure and skin injury to the face.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a medical device defect that poses a risk of dermal injury to patients. No injuries have been reported. Per the FDA rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

Medline Industries is recalling the HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap (REF DYNJMBRC2), a medical device designed to secure endotracheal tubes. The recall involves 1,332 units distributed in the US and Canada.

The device has defective adhesive elements and frame that can put additional pressure on patients' cheekbones and upper lip. Depending on how the device is positioned, this pressure may cause dermal injury to the patient's skin.

Patients and healthcare providers using this device should contact Medline Industries for instructions on safe removal or replacement.

The recalled product

Product
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Airway Management
Hazard
  • dermal-injury
  • pressure-injury
  • adhesive-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • UDI/DI 20193489005308
  • (case)
  • 10193489005301 (each)
  • All Lots

Distribution

Distribution scope not specified by the agency.

Related recalls

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