HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap… recallZ-0695-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Nov 18, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Medline Industries issued an URGENT MEDICAL DEVICE RECALL to its consignees of 11/18/2024 via USPS and email. The notice explained the issue, risk to user, and requested the destruction of the affected product. For questions, contact the Recall Department at 866-359-1704 or [email protected].
Recall details
- Recall number
- Z-0695-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 18, 2024
- Posted by the FDA
- Dec 18, 2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1332 units
- Product code
- CBH
- Distribution
- US and Canada
Product description
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
Code information (models, lots, serial numbers)
UDI/DI 20193489005308, (case), 10193489005301 (each); All Lots
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline DYNJMBRC2Medline Industries, Inc. · DEVICE, FIXATION, TRACHEAL TUBE1 recall1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 95821).
- Z-0698-2025 · Open, ClassifiedHUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page