DeRoyal 30-301Recalls & reported problems
Deroyal Industries, Inc. · Neuro Sponges · Class U
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00749756037853), received between Mar 16, 2026 and Jun 8, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Extra Components” (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
- Extra Components1
- Nonstandard Device1
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.
MalfunctionJun 8, 2026Nonstandard Device
A USER FACILITY REPORTED THROUGH A FDA MEDWATCH, "ITEMS IN PACKAGE NOT UNIFORM IN SIZE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25429916 ↗MalfunctionMar 16, 2026Extra Components
A USER FACILITY REPORTING THROUGH A MEDWATCH, "THERE WERE 11 (1/2 X 6) NEURO STRIPS IN A PACKAGE WHEN THERE SHOULD HAVE BEEN 10. THIS IS AN ITEM USED IN SURGERY THAT IS COUNTED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24605210 ↗
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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