Z-0695-2025Class II

HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device

Name: Z-0695-2025 HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-11-18
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-11-18 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device on 2024-11-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0695-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-18
Posted: 2024-12-18
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
Product code: CBH Device, Fixation, Tracheal Tube
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.
Root cause tag: manufacturing process
FDA 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 [email protected].
Quantity in commerce: 1332 units
Distribution: US and Canada
Product codes and lots: UDI/DI 20193489005308, (case), 10193489005301 (each); All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0695-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0695-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-18
Z-0696-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-18
Z-0697-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-18
Z-0698-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-18

Product code CBH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)