HUDSON RCI mBrace — Class II medical device recall Z-0698-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-12-25. Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder pu
| Recall number | Z-0698-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-11-18 |
| Classified | 2024-12-18 |
| Reported by FDA | 2024-12-25 |
| Countries outside the US | CA |
| Quantity | 768 units |
| UPC / GTIN / UDI-DI | 10193489005332, 20193489005339 |
| Model numbers | DYNJMBRC4B |
Product
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0698-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.