# FDA recall Z-0697-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2024-11-18.

## Product

HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; 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.

## Distribution

US and Canada

## Key facts

- **Recall number:** Z-0697-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-18
- **Report date:** 2024-12-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0697-2025

## Citation

> AI Analytics. FDA recall Z-0697-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0697-2025. Source: US FDA. Licensed CC0.

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