Medline recalls Hudson RCI mBrace ET Tube Holder with 4-point head strap (REF DYNJMBRC4) due to adhesive defects causing cheekbone and lip pressure. Affected units have UDI/DI 20193489005322 (case) or 10193489005325 (each).
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.
Take action
Contact the company
📍Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753
“Medline Hudson RCI mBr: Tracheal Tube Holder Risk of Cheekbone Injury.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53469-medline-hudson-rci-mbr-tracheal-tube-holder-risk-of-cheekbone. Based on FDA recall #Z-0697-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0697-2025%22&limit=1).
The FDA announced on Nov. 18, 2024, that Medline Industries LP is voluntarily recalling the HUDSON RCI mBrace tracheal tube fixation device due to potential dermal injury. The recall affects all lots of the product distributed in the U.S. and Canada.
How to tell if you have it
Brand: Medline Industries
Product: HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap
Reference Number: REF DYNJMBRC4
UDI/DI (case): 20193489005322
UDI/DI (each): 10193489005325
Lots: All Lots
The hazard
Complaint defects regarding the device's adhesive elements and frame may put additional pressure on a patient's cheekbones and upper lip, potentially causing dermal injury depending on positioning. The record does not report specific incidents or injuries.
Context
GovInfoNow's records show Medline Industries LP has issued 119 other recalls since Oct. 22, 2021. Recent brand recalls include medical kits with light failures on July 25, 2025, and Foley tray kits with incorrect labeling on July 23, 2025. Other recent recalls of similar products include the Medline Anterior Hip Pack recall (Feb. 16, 2026) and the Medline Circumcision Kits recall (Dec. 12, 2025).
How to tell if you have this one
Check for the model reference DYNJMBRC4 on the device. Units with UDI/DI 20193489005322 (case) or 10193489005325 (each) are affected. All lots are included in this recall.
Brand
Medline Industries
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US and Canada
Recall number
Product, codes & lots
Quantity
Z-0695-2025
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device; UDI/DI 20193489005308, (case), 10193489005301 (each); All Lots
1332 units
Z-0696-2025
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device; UDI/DI 20193489005315 (case), 10193489005318 (each); All Lots
360 uinits
Z-0697-2025
HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device; UDI/DI 20193489005322 (case), 10193489005325 (each); All Lots
1464 units
Z-0698-2025
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device; UDI/DI 20193489005339 (case), 10193489005332 (each); All Lots
768 units
Based on the official FDA remedy
What to do — step by step
Check Device Model
Look for the model reference DYNJMBRC4 on the device to confirm it is affected.
Contact Manufacturer
Reach out to Medline Industries for specific instructions on how to return or fix the device.
How this recall unfolded
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0697-2025 (November 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0697-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.