CLASS II ONGOING Device recall · Reported 25 Dec 2024 · FDA Enforcement Report
Hudson RCI mBrace, ET Tube Holder with Bite Block recalled
MEDLINE INDUSTRIES, LP - Northfield is recalling Hudson RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap. The recall was initiated on 18 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0698-2025
- FDA event ID
- 95821
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Nov 2024
- FDA classified
- 18 Dec 2024
- Reported
- 25 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 18 Nov 2024 | Recall initiated by company | |
| 18 Dec 2024 | Classified by FDA | +30 days |
| 25 Dec 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
Where it was distributed
US and Canada
Questions about this recall
Is Hudson RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Hudson RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap on 18 Nov 2024. The recall is Class II and its status is Ongoing. Recall number Z-0698-2025.
Why was it 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.
Which lots are affected?
UDI/DI 20193489005339 (case), 10193489005332 (each); All Lots
Where was it sold?
US and Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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