FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
- Recall number
- Z-0697-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
- Status
- Open, Classified
- Initiated
- 2024-11-18
- Posted
- 2024-12-18
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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 recalls@medline.com.
- Quantity
- 1464 units
- Distribution
- US and Canada
- Lot, serial or model codes
- UDI/DI 20193489005322 (case), 10193489005325 (each); All Lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CBH
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28