DeRoyal M8125-ARecalls & reported problems
Deroyal Industries, Inc. · IV ARMBOARD · Class 1
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00749756112475), received between Apr 27, 2026 and Apr 27, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Unexpected Color” (7 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Unexpected Color7
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2026Unexpected Color
A USER FACILITY REPORTED ON AN FDA MEDWATCH, "YELLOWISH COLOR." THIS WAS FOUND PRIOR TO USE AND DID NOT CAUSE ANY INJURIES OR OUTCOMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25003228 ↗MalfunctionApr 27, 2026Unexpected Color
A USER FACILITY REPORTED ON AN FDA MEDWATCH, "YELLOWISH COLOR." THIS WAS FOUND PRIOR TO USE AND DID NOT CAUSE ANY INJURIES OR OUTCOMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25003149 ↗MalfunctionApr 27, 2026Unexpected Color
A USER FACILITY REPORTED ON AN FDA MEDWATCH, "YELLOWISH COLOR." THIS WAS FOUND PRIOR TO USE AND DID NOT CAUSE ANY INJURIES OR OUTCOMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25003142 ↗MalfunctionApr 27, 2026Unexpected Color
A USER FACILITY REPORTED ON AN FDA MEDWATCH, "YELLOWISH COLOR." THIS WAS FOUND PRIOR TO USE AND DID NOT CAUSE ANY INJURIES OR OUTCOMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25003101 ↗MalfunctionApr 27, 2026Unexpected Color
A USER FACILITY REPORTED ON AN FDA MEDWATCH, "YELLOWISH COLOR." THIS WAS FOUND PRIOR TO USE AND DID NOT CAUSE ANY INJURIES OR OUTCOMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25003095 ↗MalfunctionApr 27, 2026Unexpected Color
A USER FACILITY REPORTED ON AN FDA MEDWATCH, "YELLOWISH COLOR." THIS WAS FOUND PRIOR TO USE AND DID NOT CAUSE ANY INJURIES OR OUTCOMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25003088 ↗MalfunctionApr 27, 2026Unexpected Color
A USER FACILITY REPORTED ON AN FDA MEDWATCH, "YELLOWISH COLOR." THIS WAS FOUND PRIOR TO USE AND DID NOT CAUSE ANY INJURIES OR OUTCOMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25003061 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.