DeRoyal 30-055Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00749756037402), received between Mar 11, 2025 and Dec 23, 2025 — classified as 3 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  A USER FACILITY REPORTED, "WHEN USING THE NEURO SPONGES REF 30-055 LOT 24112874 EXP 12/11/2029 THE PRODUCT, WHICH IS SUPPOSED TO BE X-RAY DETECTABLE WAS NOT DETECTED ON THE XRAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876853 ↗
• MalfunctionNov 6, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED VIA A MEDWATCH, "STRING CAME OFF COTTONOID OF NEURO SPONGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487989 ↗
• MalfunctionMar 11, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED, "NEURO SPONGE BROKE INTO TWO PIECES WHILE IN USE, THE PIECE WAS FOUND LYING IN THE INCISION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21576391 ↗