Devon 31146020Recalls & reported problems

Cardinal Health, Inc. · Surgical Site Mini-Marker,Prep Resistant · 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 30884521049813), received between Jan 2, 2018 and Jan 2, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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.

Most reported problems

Device problems

Leak/Splash1

Patient problems

No Patient Involvement1

Recent adverse event reports

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

MalfunctionJan 2, 2018Leak/Splash; Leak/Splash
THE CUSTOMER STATES THAT THE TEAM HAS FOUND OUR SURGICAL MARKERS TO BE BLEEDING AND LEAVING A JAGGED LINE FOR THE INCISION PLACEMENT.
Patient problems: No Patient Involvement
MAUDE report 7158399 ↗

Device details

UDI-DI	`30884521049813`
Brand	Devon
Model	31146020
Company	Cardinal Health, Inc.
Product code	FZZ · MARKER, SKIN
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jul 3, 2023

Device type (GMDN): Skin marking pen, single-use

A dedicated pen intended to be used to delineate areas on the skin surface of a patient (e.g., to outline surgical incision sites, for dermatology applications) utilizing non-toxic ink. It is typically a felt-tip pen which may include a sterile disposable ruler. This is a single-use device.

Other MARKER, SKIN devices

Devon 31145892
Cardinal Health, Inc. · MARKER, SKIN
1 report
Devon 31145777
Cardinal Health, Inc. · MARKER, SKIN
1 report
Devon 31145827
Cardinal Health, Inc. · MARKER, SKIN
1 report
Key Surgical Skin Markers SM-300
Key Surgical, Inc. · Marker, Skin
1 report

All MARKER, SKIN 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.

How reports and recalls are matched · Editorial policy · Report an error on this page