MEROCEL® 470530Recalls & reported problems

Medtronic Xomed, Inc. · DRESSING 470530 SINUSSTENT 20PK PR KNNDY · Class U

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20681490115081), received between Oct 15, 2018 and Oct 15, 2018 — classified as 1 injury.

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

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Bacterial Infection1
Sepsis1
Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryOct 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT CAME BACK TO THE EMERGENCY ROOM OF THE FACILITY WITH ECBOLI FROM THE PACKING AND SPLINT IMPLANTS.
Patient problems: Bacterial Infection; Sepsis; Unspecified Infection
MAUDE report 7964806 ↗

Device details

UDI-DI	`20681490115081`
Brand	MEROCEL®
Model	470530
Company	Medtronic Xomed, Inc.
Product code	EFQ · GAUZE/SPONGE, INTERNAL
Class	Class U
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 7, 2024

Device type (GMDN): Non-woven gauze pad

A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum; in some cases, the device’s packaging may be used as a disposable tray. This is a single-use device.

Other GAUZE/SPONGE, INTERNAL devices

McKesson 61-59220
Mckesson Medical-Surgical Inc. · Gauze/Sponge, Internal
1 recall0 reports
McKesson 61-59120
Mckesson Medical-Surgical Inc. · Gauze/Sponge, Internal
1 recall0 reports
McKesson 61-59320
Mckesson Medical-Surgical Inc. · Gauze/Sponge, Internal
1 recall0 reports
DeRoyal 30-054
Deroyal Industries, Inc. · GAUZE/SPONGE, INTERNAL
16 reports
DeRoyal 30-057
Deroyal Industries, Inc. · GAUZE/SPONGE, INTERNAL
11 reports
DeRoyal 30-060
Deroyal Industries, Inc. · GAUZE/SPONGE, INTERNAL
5 reports
DeRoyal 30-068
Deroyal Industries, Inc. · GAUZE/SPONGE, INTERNAL
4 reports
PILLING IPN004227
Teleflex Incorporated · GAUZE/SPONGE, INTERNAL
4 reports

All GAUZE/SPONGE, INTERNAL 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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