DeRoyal 30-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00749756037785), received between May 15, 2025 and Aug 8, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED ON A MEDWATCH, "DURING THE PROCEDURE THE SURGEON WAS USING 1'X3" COTTONOIDS DURING A CRANIECTOMY AND THE RADIOPAQUE STRIP ON THE COTTONOID THAT WASN'T SEWN ONTO THE COTTONOID AND KEPT PEELING OFF OF THE COTTONOID AND INTO THE PATIENT. TWO OF THE COTTONOIDS HAD PEELED OFF AND THE SURGEON HANDED NURSE THE STRIPS BACK AND THE NURSE MADE SURE THEY WERE NOT MISSING ANY STRIPS FROM THE OTHER COTTONOIDS THAT WE HAD USED DURING THE CASE. THE NURSE THEN LAID ALL OF THE COTTONOIDS WITH THE STRIPS THAT HAD COME OFF TO VERIFY THAT ALL PIECES WERE RETRIEVED AND NOT LOST. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749608 ↗
• MalfunctionAug 7, 2025Material Separation

  DURING THE PROCEDURE THE SURGEON WAS USING 1'X3" COTTONOIDS DURING A CRANIECTOMY AND THE RADIOPAQUE STRIP ON THE COTTONOID THAT WASN'T SEWN ONTO THE COTTONOID AND KEPT PEELING OFF OF THE COTTONOID AND INTO THE PATIENT. TWO OF THE COTTONOIDS HAD PEELED OFF AND THE SURGEON HANDED NURSE THE STRIPS BACK AND THE NURSE MADE SURE THEY WERE NOT MISSING ANY STRIPS FROM THE OTHER COTTONOIDS THAT WE HAD USED DURING THE CASE. THE NURSE THEN LAID ALL OF THE COTTONOIDS WITH THE STRIPS THAT HAD COME OFF TO VERIFY THAT ALL PIECES WERE RETRIEVED AND NOT LOST. ACTION TAKEN: THE PRODUCT USED WAS IDENTIFIED AS LOT NUMBER 2410700. AS A PRECAUTIONARY MEASURE, THE ASSISTANT NURSE MANAGER REMOVED ALL AFFECTED LOT 2410700 FROM CIRCULATION. THEY ALSO CONDUCTED AN INSPECTION OF OTHER DEROYAL NEURO SPONGE LOTS CURRENTLY IN STOCK. ALL REMAINING INVENTORY WAS FOUND TO BE INTACT, WITH NO ISSUES OBSERVED. THE EVENT, CONCERNS, AND THE NECESSARY PRECAUTIONS WERE COMMUNICATED TO THE OR TEAM, AND THEY WERE ADVISED ON WHAT TO LOOK OUT FOR. ADDITIONALLY, MATERIALS MANAGEMENT WAS INFORMED OF THE ISSUE. OR WAS ADVISED TO DISCARD ALL DEROYAL 1X3 NEURO SPONGES, AS THERE IS AN ALTERNATIVE MANUFACTURER¿S PRODUCT AVAILABLE IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737631 ↗
• InjuryMay 20, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED, "FIBRE TISSUE HAD TO BE REMOVED FROM BRAIN TISSUE. LENGTH OF DELAY UNKNOWN."

  Patient problems: Insufficient Information

  MAUDE report 22055263 ↗
• MalfunctionMay 15, 2025Material Disintegration; Material Disintegration

  A USER FACILITY REPORTED, "OPENED PACK OF NEURO SPONGES 1 IN X 3 IN AND LATER FOUND FLOATING PIECE UNATTACHED TO ANY SPONGES FOUND BY SURGEON IN PATIENT'S RIGHT NASAL CAVITY VIA ENDOSCOPE DURING SURGERY. PIECE WAS TAKEN OUT AND THE ENTIRE PACK WAS TAKEN OFF THE STERILE FIELD. REPORTED TO CHARGE NURSE AND MANAGER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029254 ↗
• MalfunctionMay 15, 2025Extra Components; Extra Components

  A USER FACILITY REPORTED, "PACK OF THE NEURO SPONGES WAS OPENED DURING CASE AND COUNTED. COUNT WAS 11, RECOUNTED, AND COUNT WAS 11 AGAIN. REMOVED FROM THE FIELD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029251 ↗