DeRoyal 30-303Recalls & reported problems
Deroyal Industries, Inc. · Neuro Sponges · Class U
- 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 00749756037761), received between Jul 16, 2025 and Jul 16, 2025 — classified as 1 malfunction.
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
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.
MalfunctionJul 16, 2025Extra Components; Extra Components
A USER FACILITY REPORTED, "NEURO STRIP SPONGE HAD 11 STRIPS INSTEAD OF 10 ONLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22519939 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.