Medline Industries is recalling 3,924 Hudson RCI mBrace ET Tube Holders because defects in the device's adhesive and frame can put excessive pressure on a patient's face. All lots of the several models are affected, including versions with 2-point or 4-point head straps and optional bite blocks. This recall was initiated after reports that the device was causing injuries to patients' cheekbones and lips depending on how it was positioned.
The adhesive elements and frame of the tube holder can press too firmly against the cheekbones and upper lip, leading to dermal (skin) injuries. Multiple incidents of skin injury have already been reported in patient complaints.
Quantity: 1332 units; Recall #: Z-0695-2025
Quantity: 360 units; Recall #: Z-0696-2025
Quantity: 1464 units; Recall #: Z-0697-2025
Quantity: 768 units; Recall #: Z-0698-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.