Vistec 7148 (REF 7148-)Recalls & reported problems
Cardinal Health 200, LLC · Vistec X-Ray Detectable Sponges · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20192253047230), received between Apr 22, 2025 and Jun 17, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Component Missing” (2 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 Missing2
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2026Component Missing
THE CUSTOMER REPORTED INCORRECT RAYTEC SPONGES, 9 INSTEAD OF 10 COUNTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25536910 ↗MalfunctionNov 13, 2025Unraveled Material; Unraveled Material
THE CUSTOMER REPORTED THAT THE RAYTECS INSIDE THE PACK WERE COMING APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23544102 ↗MalfunctionApr 22, 2025Component Missing; Component Missing
THE CUSTOMER REPORTED THAT THE RAYTEC DID NOT HAVE BLUE RADIOPAQUE MARKER ON FRONT AND BACK FOLDS. IF NOT PLACED ON BACK TABLE APPROPRIATELY WOULD HAVE BEEN MISTAKEN AS GAUZE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21885000 ↗
Other Gauze/sponge, internal, x-ray detectable devices
- Vistec 7317Cardinal Health, Inc. · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall80 reports
- Situate G0804-12P02CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE120 reports
- 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.