FDA Device recall Z-0697-2025
HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4
- FDA Device
- Class II
- ongoing
- Published 2024-12-25
On 2024-12-25 the FDA classified a Class II recall of HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4 by Medline Industries Northfield, citing 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 w….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0697-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-18 |
| Published | 2024-12-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | n/a |
Product
HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
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.
Identifiers
| code_info | UDI/DI 20193489005322 (case), 10193489005325 (each); All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0697-2025%22
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