DeRoyal 77-400274Recalls & reported problems
Deroyal Industries, Inc. · DECANTER 50C · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00749756281928), received between Aug 18, 2025 and Sep 25, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
Most reported problems
Device problems
- Break2
- Material Fragmentation2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2025Material Fragmentation; Material Fragmentation
A USER FACILITY REPORTED WITH A MEDWATCH (#(B)(4)), "TIPS BROKE OFF IN FLUID BAG."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23144787 ↗MalfunctionSep 15, 2025Break
TIPS BROKE OFF IN FLUID BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23050548 ↗MalfunctionAug 20, 2025Material Fragmentation; Material Fragmentation
A USER FACILITY REPORTED WITH A MEDWATCH (B)(4), "TIP BROKE OFF INTO THE IV BAG."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22852945 ↗MalfunctionAug 18, 2025Break
TIP BROKE OFF INTO THE IV BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22827103 ↗
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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
- 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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