Medline recalls Hudson RCI mBrace ET Tube Holder with 4-point head strap (REF DYNJMBRC4) due to adhesive defects causing cheekbone and lip pressure. Affected units have UDI/DI 20193489005322 (case) or 10193489005325 (each).
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 mBrace ET Tube Holders with 4-point head straps because adhesive issues may cause cheekbone and lip injuries. This device is used in medical settings to secure tracheal tubes.
The device's adhesive and frame can create pressure on the patient's cheekbones and upper lip. If the device is positioned incorrectly, it may cause skin injuries like bruising or cuts.
Healthcare professionals using this tracheal tube fixation device in hospitals or clinics. Patients with tracheal tubes are at risk if the device causes pressure on their cheekbones or lips.
Check for the model reference DYNJMBRC4 on the device. Units with UDI/DI 20193489005322 (case) or 10193489005325 (each) are affected. All lots are included in this recall.
Look for the model reference DYNJMBRC4 on the device to confirm it is affected.
Reach out to Medline Industries for specific instructions on how to return or fix the device.
The device may cause cheekbone or lip injuries if the adhesive or frame creates improper pressure. Do not use until the manufacturer provides instructions.
Check for model reference DYNJMBRC4 and UDI/DI numbers 20193489005322 (case) or 10193489005325 (each).
Contact Medline Industries for specific instructions on returning or fixing the device.
We’ve drafted a message you can send Medline Industries to request your refund or repair — edit it as you like.
Subject: Recall Z-0697-2025 — Medline Industries Medline Industries Hello, I own a Medline Industries that is covered by recall Z-0697-2025 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.
