Curity 6318Recalls & reported problems
Cardinal Health, Inc. · Gauze Sponges,8 Ply · Class 1
Data updated Oct 18, 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 10884521059092), received between Jun 27, 2019 and Jun 27, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2019Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT THE GAUZE WAS LINTING AND LEAVING FIBERS ALL OVER THE INSTRUMENTS. THE CUSTOMER CONFIRMED THAT THIS HAPPENED IN A SURGICAL SETTING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8739401 ↗
Other FIBER, MEDICAL, ABSORBENT devices
- MEDLINE MDT2168204Medline Industries, Inc. · FIBER, MEDICAL, ABSORBENT18 reports
- MEDLINE MDT2168284Medline Industries, Inc. · FIBER, MEDICAL, ABSORBENT14 reports
- MEDLINE MDT2168286Medline Industries, Inc. · FIBER, MEDICAL, ABSORBENT11 reports
- MEDLINE MDT2168304Medline Industries, Inc. · FIBER, MEDICAL, ABSORBENT6 reports
- MEDLINE MDT2168210Medline Industries, Inc. · FIBER, MEDICAL, ABSORBENT5 reports
- Curity 6939Cardinal Health, Inc. · FIBER, MEDICAL, ABSORBENT4 reports
- MEDLINE MDT2168202Medline Industries, Inc. · FIBER, MEDICAL, ABSORBENT4 reports
- CARDINAL HEALTH 28700-006Cardinal Health 200, LLC · FIBER, MEDICAL, ABSORBENT4 reports
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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