CARDINAL HEALTH 4854 (UDI 20192253061755)Recalls & reported problems

Cardinal Health 200, LLC · SHOECOVER DURA FIT XL · Class 1

Data updated Oct 18, 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 20192253061755), received between Nov 10, 2025 and Nov 10, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Product Quality Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Product Quality Problem1

Patient problems

Concussion1

Recent adverse event reports

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

InjuryNov 10, 2025Product Quality Problem; Product Quality Problem
THE CUSTOMER REPORTED, "ON THIS MORNING¿S SYSTEM HUDDLE, A TEAM MEMBER FALL WITH INJURY WAS REPORTED WITH THE CULPRIT BEING SHOE COVERS WITHOUT NON-SKID BOTTOMS. FLOOR HAD BEEN CLEANED AND WAS SAFE IF WEARING NORMAL SHOES, BUT WAS ¿SLICK AS GLASS¿ ACCORDING TO DR. OCHSENBEIN WITH THE SHOE COVERS". THE TEAM MEMBER HIT HER HEAD FROM THE FALL WHICH CAUSED A CONCUSSION. SHE WAS TREATED IN THE EMERGENCY ROOM AND SCANNED FOR FURTHER INJURIES. EVENT DATE IS UNKNOWN.
Patient problems: Concussion
MAUDE report 23514725 ↗

Device details

UDI-DI	`20192253061755`
Brand	CARDINAL HEALTH
Model	4854
Company	Cardinal Health 200, LLC
Product code	FXP · COVER, SHOE, OPERATING-ROOM
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 28, 2022

Device type (GMDN): Shoe cover

A loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device.

Other COVER, SHOE, OPERATING-ROOM devices

Halyard 69252
O&M Halyard, Inc. · COVER, SHOE, OPERATING-ROOM
26 reports
Halyard 69254
O&M Halyard, Inc. · COVER, SHOE, OPERATING-ROOM
11 reports
Halyard 69353
O&M Halyard, Inc. · COVER, SHOE, OPERATING-ROOM
6 reports
Regard™ CVRBTTIEL-REG
Resource Optimization & Innovation, L.L.C. · Cover, Shoe, Operating-Room
1 report
Halyard 69195
O&M Halyard, Inc. · COVER, SHOE, OPERATING-ROOM
1 report
CARDINAL HEALTH 4850
Cardinal Health 200, LLC · COVER, SHOE, OPERATING-ROOM
1 report
CARDINAL HEALTH 4854
Cardinal Health 200, LLC · COVER, SHOE, OPERATING-ROOM
1 report
Regard™ CVRBTTIEXL-REG
Resource Optimization & Innovation, L.L.C. · Cover, Shoe, Operating-Room
1 report

All COVER, SHOE, OPERATING-ROOM 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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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