ET Tube Holder Recalled for Risk of Facial Skin Injury
Medline's HUDSON RCI mBrace ET tube holder is being recalled because its adhesive and frame design may put excessive pressure on patients' cheekbones and upper lip, potentially causing skin injury.
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: FDA Class II device with potential for dermal injury from device-induced facial pressure. No illnesses or injuries have been reported; the hazard is theoretical depending on device positioning, placing this at the maximum threshold for unconfirmed harm to at-risk patients.
Plain-English summary
Medline Industries is recalling the HUDSON RCI mBrace, an endotracheal (ET) tube holder designed to secure breathing tubes in patients. The device is a tracheal tube fixation device with a bite block and two-point head strap.
The recall has been initiated because of defects in the adhesive elements and the frame of the holder. Depending on how the device is positioned, these defects can put additional pressure on the patient's cheekbones and upper lip, which may result in dermal (skin) injury.
The recall affects approximately 360 units that were distributed in the United States and Canada across all production lots. Patients or healthcare providers currently using this device should contact Medline Industries for guidance on next steps.
The recalled product
- Product
- HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 360
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 (3)
- UDI/DI 20193489005315 (case)
- 10193489005318 (each)
- All Lots
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · pressure injury
See all →- SevereErbe ERBECRYO 2 Cryosurgical Unit Recalled Due to Rupture Risk
FDA (Devices) · 2026-08-19
- HighET Tube Holder Recalled Due to Skin Pressure Defect Risk
FDA (Devices) · 2024-12-25
- HighHUDSON RCI mBrace ET Tube Holder Risks Facial Dermal Injury
FDA (Devices) · 2024-12-25
- HighTracheal Tube Holder Recalled for Defect Causing Potential Skin Pressure Injury
FDA (Devices) · 2024-12-25
- HighArjoHuntleigh Flowtron ACS900 Medical Pump Recalled for Deflation Failure
FDA (Devices) · 2017-07-19