Medline recalls Hudson RCI mBrace ET Tube Holder due to adhesive defects causing cheekbone and lip pressure that may lead to skin injury. Affected units have specific model numbers and were sold in 2019.
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.
Medline is recalling Hudson RCI mBr: a tracheal tube fixation device that may cause cheekbone or lip injuries due to adhesive defects. This affects medical devices used during intubation procedures.
The device's adhesive elements and frame can create pressure on the patient's cheekbones and upper lip. If the device is positioned incorrectly, this may cause skin injury depending on the patient's anatomy and the device's fit.
Healthcare professionals using the device during intubation procedures. Patients receiving mechanical ventilation are at risk if the device causes improper pressure on their face.
The product has model number REF DYNJMBRC2. It was sold as a tracheal tube fixation device with UDI/DI numbers 20193489005308 (case) and 10193489005301 (each). All lots are affected.
Look for model number REF DYNJMBRC2 on the device packaging or label.
The device may cause skin injury if it creates improper pressure on the cheekbones or upper lip due to adhesive defects, but it is not inherently dangerous in normal use.
Check for model number REF DYNJMBRC2 and UDI/DI numbers 20193489005308 (case) or 10193489005301 (each).
The recall does not specify a remedy, so contact Medline directly for guidance.
We’ve drafted a message you can send Medline Industries to request your refund or repair — edit it as you like.
Subject: Recall Z-0695-2025 — Medline Industries Medline Industries Hello, I own a Medline Industries that is covered by recall Z-0695-2025 from Medline Industries. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
