MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2024 - (Recall #: Z-0696-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device

Product Classification:

Class II

Date Initiated: November 18, 2024

Date Posted: December 25, 2024

Recall Number: Z-0696-2025

Event ID: 95821

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 360 uinits

Code Information:

UDI/DI 20193489005315 (case), 10193489005318 (each); All Lots

Distribution Pattern:

US and Canada

Voluntary or Mandated:

Voluntary: Firm initiated