VistecRecalls & reported problems across all models
Cardinal Health 200, LLC · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 5 models of Vistec by Cardinal Health 200, LLC in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between May 21, 2024 and Jun 17, 2026 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Component Missing” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Vistec problems
Device problems
- Component Missing12
- Material Fragmentation10
- Material Disintegration5
- Material Frayed5
- Material Separation5
- Incorrect Measurement1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
Vistec models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Vistec 7317Gauze/sponge, internal, x-ray detectable19 reports
- Vistec 7318Gauze/sponge, internal, x-ray detectable10 reports
- Vistec 7148Gauze/sponge, internal, x-ray detectable3 reports
- Vistec 7320Gauze/sponge, internal, x-ray detectable2 reports
- Vistec 7462Gauze/sponge, internal, x-ray detectable1 report
Recent Vistec adverse event reports
The 15 most recent reports across all models, 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 ↗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 21, 2026Component Missing
THE CUSTOMER REPORTED A PACKET OF CARDINAL HEALTH BRAND VISTEC X-RAY DETECTABLE SPONGES HAD ONLY 9 SPONGES INSTEAD OF TEN. PER THE CUSTOMER, THIS SHORTAGE CREATES A POSSIBLE ISSUE IN ACCOUNTING FOR THE NUMBER OF SPONGES USED DURING SURGICAL PROCEDURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24938813 ↗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 26, 2026Material Fragmentation
THE CUSTOMER REPORTED THE MATERIAL IS SHEDDING FIBERS AND LEAVING PARTICLES ON THE SURGICAL FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24706387 ↗MalfunctionJan 9, 2026Component Missing
THE CUSTOMER REPORTED ONLY 9 EA SPONGES INSIDE THE SEALED TRAY. THE KIT COULD NOT BE USED SINCE ALL 10 EACH WEREN'T ACCOUNTED FOR IN THE PACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24019971 ↗MalfunctionDec 10, 2025Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT THEY OPENED TWO PACKS AND RUBBED THEM AROUND AND NOTED THAT THEY ALSO WERE LEAVING BEHIND TINY THREADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23772105 ↗MalfunctionDec 10, 2025Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT DURING A PROCEDURE, AN ADDITIONAL PACK OF RAYTEC WAS OPENED TO THE FIELD. WHEN USING, IT WAS NOTICED THAT THEY WERE LEAVING TINY THREADS OF THE RAYTEC BEHIND. THE CIRCULATOR OPENED ANOTHER PACK AND RUBBED THEM AROUND AND NOTED THAT THEY ALSO WERE LEAVING BEHIND TINY THREADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23772089 ↗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 ↗MalfunctionNov 5, 2025Component Missing; Component Missing
THE CUSTOMER REPORTED THAT THE CARDINAL VISTEC XRAY DETECTABLE SPONGE PACK LOT # 25C019262 CONTAINED ONLY NINE SPONGES INSTEAD OF TEN SPONGES. ON 17NOV2025, THE IN CUSTOMER STATED THAT THE ISSUE WAS IDENTIFIED BEFORE THE PRODUCT WAS PLACED INTO CLINICAL USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23479902 ↗MalfunctionSep 12, 2025Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT THE PRODUCT IS LINTING REALLY BAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23042637 ↗MalfunctionSep 12, 2025Component Missing; Component Missing
THE CUSTOMER REPORTED THAT TWO ONLY HAD 9 IN THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23042631 ↗MalfunctionSep 12, 2025Component Missing; Component Missing
THE CUSTOMER REPORTED THE PRODUCT CONTAINED ONLY 9 SPONGES INSTEAD OF 10 SPONGES WHEN OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23042371 ↗MalfunctionSep 11, 2025Component Missing; Component Missing
THE CUSTOMER REPORTED THAT THERE WAS ONLY 9 IN THE PACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23025903 ↗
Other Cardinal Health 200, LLC products
- JACKSON-PRATT20 models · 13 reports · 19 recalls
- Monoject35 models · 96 reports · 11 recalls
- CONVERTORS38 models · 40 reports · 11 recalls
- Argyle33 models · 58 reports · 7 recalls
- Salem Sump31 models · 40 reports · 7 recalls
- Dover45 models · 241 reports · 2 recalls
- Kendall31 models · 51 reports · 3 recalls
- Kangaroo35 models · 130 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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