Vistec 7462 (UDI 20192253047315)Recalls & reported problems

Cardinal Health 200, LLC · X-Ray Detectable Sponges 12 Ply 8 x 4 in. (20.3 x 10.2 cm) · Class 1

All models of Vistec (5)

Data updated Oct 16, 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 20192253047315), received between May 27, 2025 and May 27, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Component Missing1

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.

MalfunctionMay 27, 2025Component Missing; Component Missing
THE CUSTOMER REPORTED THAT THEY RECEIVED 9 SPONGES INSTEAD OF 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22087506 ↗

Device details

UDI-DI	`20192253047315`
Brand	Vistec
Model	7462
Company	Cardinal Health 200, LLC
Product code	GDY · Gauze/sponge, internal, x-ray detectable
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	Oct 22, 2025

Device type (GMDN): Radiopaque woven surgical sponge

A non-medicated device made from woven gauze (e.g., 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, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.

Other Gauze/sponge, internal, x-ray detectable devices

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Situate G0804-12P02CN-1
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Situate G0404-16P01CN-1
Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
114 reports
Situate G0804-16P02CN-1
Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
2 recalls1 report
Situate L1818-04P01C-1
Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
1 recall20 reports
Situate G0404-16P01C-1
Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
60 reports
AMD-RITMED 85995C
AMD Medicom Inc · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
1 recall0 reports
Medical Action Industries 403
Medical Action Industries Inc. · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
1 recall0 reports

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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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