Vistec 7318 (UDI 20192253047292)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
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20192253047292), received between May 21, 2024 and Apr 29, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Component Missing” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Component Missing3
- Material Frayed3
- Material Separation3
- Incorrect Measurement1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2026Component Missing
THE CUSTOMER REPORTED THAT UPON OPENING THE PACKAGE OF X-RAY DETECTABLE SPONGES, THERE WERE 12 SPONGES IN THE PACKAGE INSTEAD OF 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035135 ↗MalfunctionApr 29, 2026Material Frayed
THE CUSTOMER REPORTED THAT THE PRODUCT IS FRAYING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25034714 ↗MalfunctionApr 14, 2026Material Separation
THE CUSTOMER REPORTED THAT RAY-TEC SPONGES WERE INSPECTED PRIOR TO USE AT THE OR GENERAL SURGERY. DURING INSPECTION, TWO RAY-TEC SPONGES FROM A PACKAGE OF TEN WERE FOUND TO HAVE FIBER SEPARATING AND SHEDDING. THE MANAGEMENT WAS NOTIFIED IMMEDIATELY UPON DISCOVERY. THE SURGICAL TEAM WAS MADE AWARE AND REMAINED VIGILANT THROUGHOUT THE PROCEDURE, REGULARLY CHECKING FOR ANY POTENTIAL FIBER SHEDDING TO ENSURE NO MATERIAL WAS RETAINED. THE ISSUE WAS NOTICED DURING PREPARATION AND BOTH AFFECTED RAY-TEC SPONGES WERE IMMEDIATELY REMOVED FROM THE STERILE BACK TABLE AND NOT USED ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24875309 ↗MalfunctionMar 5, 2025Component Missing; Component Missing
THE CUSTOMER REPORTED THAT THE VISTEC SPONGE THAT ONLY HAD 9 SPONGES IN IT INSTEAD OF 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21529683 ↗MalfunctionMar 5, 2025Material Separation; Material Separation
THE CUSTOMER REPORTED THAT THE GAUZE IS FRAYING. THERE WAS NO MEDICAL INTERVENTION REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21529636 ↗MalfunctionMar 5, 2025Material Separation; Material Separation
THE CUSTOMER REPORTED THAT THE RAYTECHS ARE FALLING APART, SINGLE STERILE AND IN THE PACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21529575 ↗MalfunctionFeb 25, 2025Material Frayed; Material Frayed
THE CUSTOMER REPORTED 1 PACKAGE OF 7318 GAUZE PADS WITH FRAYED GAUZE. THERE WAS NO MEDICAL INTERVENTION REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21458788 ↗MalfunctionDec 3, 2024Material Frayed; Material Frayed
THE CUSTOMER REPORTED THAT THE VISTEC GAUZE IS FRAYING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20836157 ↗MalfunctionSep 12, 2024Component Missing; Component Missing
THE CUSTOMER REPORTED THAT THEY HAD AN INCIDENT YESTERDAY WHERE THE HEART ROOM OPENED A PACK OF RAYTEC AND THE BLUE XRAY STRANDS WERE MISSING OUT OF ONE OF THE RAYTECS. THE CUSTOMER REPLACED THE RAYTECS WITH A NEW PACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20200866 ↗MalfunctionMay 21, 2024Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE PACKAGE HAD 13 SPONGES INSTEAD OF 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19362210 ↗
Other Gauze/sponge, internal, x-ray detectable devices
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- Situate G0404-16P01CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE114 reports
- Situate G0804-16P02CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE2 recalls1 report
- Situate L1818-04P01C-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall20 reports
- Situate G0404-16P01C-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE60 reports
- AMD-RITMED 55992CAMD Medicom Inc · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall0 reports
- AMD-RITMED 85995CAMD Medicom Inc · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.