Devon 31145827Recalls & reported problems

Cardinal Health, Inc. · Skin Marker Fine Tip with Ruler · 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 10884521208728), received between Dec 26, 2017 and Dec 26, 2017 — 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.

MalfunctionDec 26, 2017Leak/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 7145617 ↗

Device details

UDI-DI	`10884521208728`
Brand	Devon
Model	31145827
Company	Cardinal Health, Inc.
Product code	FZZ · MARKER, SKIN
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 15, 2019

Device type (GMDN): Open-surgery electrosurgical electrode, monopolar, reusable

An invasive, monopolar, electrical conductor intended to be attached to an electrosurgical handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Other MARKER, SKIN devices

Devon 31146020
Cardinal Health, Inc. · MARKER, SKIN
1 report
Devon 31145892
Cardinal Health, Inc. · MARKER, SKIN
1 report
Devon 31145777
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.

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