DeRoyal 30-059Recalls & reported problems
Deroyal Industries, Inc. · Neuro Sponges · Class U
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756037419), received between Feb 20, 2025 and Feb 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (1 report).
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
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2025Material Separation; Material Separation
A USER FACILITY REPORTED, THAT THEY HAVE RECEIVED INFORMATION FROM ONE OF OUR OPERATING ROOMS THAT THEY ARE HAVING ISSUES WITH THE RADIOPAQUE STRIP SEPARATING FROM THE NEURO SPONGE FROM THE SPONGES INCLUDED IN ONE OF OUR CUSTOM PACKS WE RECEIVE FROM CARDINAL. AS I MENTIONED, WE HAVE A TEAM WORKING WITH CARDINAL BUT I WANTED TO GET THIS INFORMATION TO YOU AS WELL. THERE HAVE BEEN 3 INCIDENTS, THE FIRST WAS A 1X1, THE SECOND AND THIRD THEY ARE LOOKING TO GET MORE INFORMATION ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21424552 ↗
Other GAUZE/SPONGE, INTERNAL devices
- McKesson 61-59220Mckesson Medical-Surgical Inc. · Gauze/Sponge, Internal1 recall0 reports
- McKesson 61-59120Mckesson Medical-Surgical Inc. · Gauze/Sponge, Internal1 recall0 reports
- McKesson 61-59320Mckesson Medical-Surgical Inc. · Gauze/Sponge, Internal1 recall0 reports
- DeRoyal 30-054Deroyal Industries, Inc. · GAUZE/SPONGE, INTERNAL16 reports
- DeRoyal 30-057Deroyal Industries, Inc. · GAUZE/SPONGE, INTERNAL11 reports
- DeRoyal 30-060Deroyal Industries, Inc. · GAUZE/SPONGE, INTERNAL5 reports
- DeRoyal 30-068Deroyal Industries, Inc. · GAUZE/SPONGE, INTERNAL4 reports
- PILLING IPN004227Teleflex Incorporated · GAUZE/SPONGE, INTERNAL4 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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