FDA Device recall Z-0696-2025
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B
- FDA Device
- Class II
- ongoing
- Published 2024-12-25
On 2024-12-25 the FDA classified a Class II recall of HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B by Medline Industries Northfield, citing 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 w….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0696-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-18 |
| Published | 2024-12-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | n/a |
Product
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
Reason
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.
Identifiers
| code_info | UDI/DI 20193489005315 (case), 10193489005318 (each); All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Medline Industries Northfield
- Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C
FDA Device · Class I · 2025-10-01 · Medline Industries Northfield - Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B
FDA Device · Class I · 2025-10-01 · Medline Industries Northfield - ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box,…
FDA Drug · Class II · 2025-09-03 · Medline Industries Northfield - H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PAR…
FDA Drug · Class II · 2025-09-03 · Medline Industries Northfield - Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH…
FDA Device · Class I · 2025-09-03 · Medline Industries Northfield
All Medline Industries Northfield recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0696-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.