Medline DYNJMBRC2Recalls & reported problems
Medline Industries, Inc. · ETTUBE FASTENR, MBRACE, 2PT STRAP · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10193489005301), received between Nov 6, 2024 and Nov 6, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- Nov 18, 2024Open, Classified
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.
Z-0695-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Tissue Breakdown1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE FACILITY, "A MALE PATIENT IN HIS 40S PRESENTED WITH A BREAKDOWN OF THE UPPER LIP, INCLUDING AN OPEN WOUND WITH ACTIVE BLEEDING."
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 20624884 ↗
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- AnchorFast SlimFit 9787Hollister Incorporated · DEVICE, FIXATION, TRACHEAL TUBE1 recall4 reports
- AnchorFast Guard Select 9700Hollister Incorporated · DEVICE, FIXATION, TRACHEAL TUBE1 recall1 report
- Medline DYNJMBRC4BMedline Industries, Inc. · DEVICE, FIXATION, TRACHEAL TUBE1 recall0 reports
- AnchorFast 9799Hollister Incorporated · DEVICE, FIXATION, TRACHEAL TUBE21 reports
- HUDSON RCI IPN914324Teleflex Incorporated · DEVICE, FIXATION, TRACHEAL TUBE6 reports
- Dale Endotracheal Tube Holder 270Dale Medical Products, Inc. · Device, Fixation, Tracheal Tube6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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