DeRoyal 30-033Recalls & reported problems

Deroyal Industries, Inc. · Cotton Balls, Double Strung · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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 00749756027038), received between Aug 12, 2025 and Aug 12, 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

Last 36 months. The most recent month may be incomplete.

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.

MalfunctionAug 12, 2025Extra Components; Extra Components
A USER FACILITY REPORTED, "STERILE COTTON BALL PACKAGE WAS OPENED AND COUNTED; PACKAGE SAYS 5 COTTON BALLS, BUT CONTENTS EQUALED 10 WHEN COUNTED BY SURGICAL TECH AND VERIFIED BY CIRCULATING RN. THE EVENT AND PACKAGE INFORMATION WAS SENT TO [REDACTED], MATERIALS MANAGER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786249 ↗

Device details

UDI-DI	`00749756027038`
Brand	DeRoyal
Model	30-033
Company	Deroyal Industries, Inc.
Product code	GDY · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 8, 2021

Device type (GMDN): General-purpose surgical sponge

A non-medicated cushion-like mass made of absorbent materials (e.g., woven gauze, cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge or cottonoid pad/pattie, it may also be used for prepping the patient. It does not contain special features to help detect gossypiboma (sponge left inside patient) [i.e., it is not radiopaque]. This is a single-use device.

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All GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices →

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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