Curity 1806Recalls & reported problems
Cardinal Health, Inc. · Gauze Sponges,8 Ply · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521058576), received between Dec 4, 2019 and May 6, 2021 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Contamination” (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.
Most reported problems
Device problems
- Contamination1
- Contamination /Decontamination Problem1
- Material Discolored1
- Problem with Sterilization1
Patient problems
- Inflammation1
- Local Reaction1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2021Material Discolored; Problem with Sterilization; Material Discolored; Problem with Sterilization
THE CUSTOMER STATED THAT IT LOOKS AS IF THE GAUZE PAD IS BURNT CAUSING HIM TO HAVE A REACTION. THE CUSTOMER FURTHER STATED THAT HE WENT TO THE ER FOR A TOOTH EXTRACTION. THE DOCTOR GAVE HIM A GAUZE PAD TO HELP STOP THE BLEEDING AND HE PUT THE GAUZE PAD IN HIS MOUTH FOR TWO HOURS AND NOTICED A STRANGE TASTE. THE CUSTOMER FURTHER STATED THAT THE AREA WHERE THE GAUZE WAS PLACED HAS TURNED BLACK, HE EXPERIENCED SWELLING, AND LOST 30 LBS. ANTIBIOTICS WERE PRESCRIBED.
Patient problems: Inflammation; Local Reaction
MAUDE report 11784948 ↗MalfunctionJul 14, 2020Contamination /Decontamination Problem
UPON REMOVING THE GAUZE SPONGE FROM ITS PACKAGING, THE NURSE NOTICED THE GAUZE CONTAINED BLACK FLECK PIECES.
Patient problems: No Patient Involvement
MAUDE report 10270162 ↗MalfunctionDec 4, 2019Contamination
RN OPENED A CURITY 2X2 STERILE GAUZE PACKET TO USE ON A PATIENT WHEN REMOVING THEIR PIV. THE GAUZE CONTAINED WHAT LOOKED TO BE A PIECE OF BLACK DUCT TAPE WRAPPED UP INSIDE THE GAUZE. RN SET ASIDE THE GAUZE TO REPORT LATER AND OPENED A FRESH GAUZE FOR USE WITH THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9409724 ↗
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
- CARDINAL HEALTH 28700-006Cardinal Health 200, LLC · FIBER, MEDICAL, ABSORBENT4 reports
- MEDLINE MDT2168202Medline Industries, Inc. · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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