DeRoyal 30-038NSRecalls & reported problems
Deroyal Industries, Inc. · Tonsil Sponges · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756162920), received between Feb 19, 2026 and Feb 19, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2026Material Separation
A DISTRIBUTING FACILITY REPORTED THROUGH A MEDWATCH, "COTTON BALL FALLS OFF STRING DURING USE.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388014 ↗MalfunctionFeb 19, 2026Material Separation
A DISTRIBUTING FACILITY REPORTED THROUGH A MEDWATCH, "COTTON BALL FALLS OFF STRING DURING USE.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388011 ↗
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- Situate G0804-16P02CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE2 recalls1 report
- Situate L1818-04P01C-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall20 reports
- Situate G0404-16P01C-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE60 reports
- AMD-RITMED 55992CAMD Medicom Inc · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall0 reports
- AMD-RITMED 85995CAMD Medicom Inc · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.