Dermacea 441601Recalls & reported problems
Cardinal Health, Inc. · X-Ray Sponges,16 Ply · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884527021239), received between Sep 13, 2019 and Jun 6, 2024 — classified as 1 injury, 16 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (7 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
- Material Fragmentation7
- Component Missing5
- Material Frayed3
- Device Misassembled During Manufacturing /Shipping2
- Material Disintegration2
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient5
- Insufficient Information3
- Foreign Body In Patient1
- No Patient Involvement1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 6, 2024Component Missing; Component Missing
THE CUSTOMER REPORTED RECEIVING 9 OUT OF 10 GAUZES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19476846 ↗MalfunctionJan 7, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
THE CUSTOMER REPORTED THAT THE PACKAGE CONTAINED 9 PIECES INSTEAD OF 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13192588 ↗MalfunctionDec 28, 2021Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
THE CUSTOMER REPORTED THAT ONE PACK OF SPONGES CONTAINED 11 PIECES INSTEAD OF 10 AND ANOTHER CONTAINED 9 INSTEAD OF 10. NO INJURIES OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13094399 ↗MalfunctionSep 15, 2021Component Missing; Component Missing
CUSTOMER REPORTS: THE PACKAGE CONTAINED 5 GAUZE INSTEAD OF 10.
Patient problems: Insufficient Information
MAUDE report 12476343 ↗MalfunctionApr 15, 2021Component Missing; Component Missing
THE CUSTOMER REPORTED THAT THE GAUZE ONLY HAD 8 EACH INSTEAD OF 10 EACH. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11673263 ↗InjuryApr 1, 2021Material Fragmentation; Material Fragmentation
THE CUSTOMER STATED THERE WAS A WHITE SUBSTANCE THAT APPEARED TO BE LINT, FALLING FROM THE GAUZE. THE LINT FELL INTO THE PATIENT'S OPEN WOUND AND THE SURGEON IRRIGATED THE WOUND TO REMOVE IT.
Patient problems: Foreign Body In Patient
MAUDE report 11604141 ↗MalfunctionJan 27, 2021Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT THE GAUZE WAS COMING APART. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11240045 ↗MalfunctionDec 17, 2020Material Disintegration; Material Frayed; Material Disintegration; Material Frayed
THE CUSTOMER REPORTED THAT THE RAYTEC GAUZE IS FRAYING. THE ISSUE WAS DISCOVERED DURING A PROCEDURE. THE RAYTEC WAS REMOVED FROM FIELD AND A NEW PACK OPENED. THEY TRIED TO REMOVE AS MANY LOOSE THREADS AS POSSIBLE. THERE WAS NO DELAY TO THE CASE AND NO SIGNS OF HARM TO PATIENT AS OF NOW. ON 16-DEC-2020 ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE RAYTEC WAS FRAYING AND SHEDDING AND TO THEIR KNOWLEDGE THERE WERE NONE WENT INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11033579 ↗MalfunctionDec 16, 2020Material Fragmentation; Material Frayed
RAYTEC GAUZE IS FRAYING AND LEAVING THREADS ON STERILE FIELD. THERE WAS PATIENT CONTACT. RAYTEC WAS REMOVED FROM FIELD, AND A NEW PACK OF RAYTEC WAS OPENED. TRIED TO REMOVE AS MANY LOOSE THREADS AS POSSIBLE. THE GAUZE WAS CONTAINED IN ROI CPS, LLC CUSTOM PACK 880087014, LOT #: 82828N, GS00087N.
Patient problems: Insufficient Information
MAUDE report 11015570 ↗MalfunctionNov 24, 2020Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THE RAYTEC GAUZE IS FRAYING AND LEAVING THREADS ON STERILE FIELD. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10895364 ↗MalfunctionNov 24, 2020Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THE RAYTEC GAUZE IS FRAYING AND LEAVING THREADS ON THE STERILE FIELD. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10895318 ↗MalfunctionNov 24, 2020Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THE RAYTEC GAUZE IS FRAYING AND LEAVING THREADS ON THE STERILE FIELD. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10895207 ↗MalfunctionNov 13, 2020Material Fragmentation; Material Frayed
RAYTEC GAUZE IS FRAYING AND LEAVING THREADS ON STERILE FIELD. THERE WAS PATIENT CONTACT. RAYTEC WAS REMOVED FROM THE FIELD AND NEW STERILE PACK OF RAYTEC WAS OPENED. TRIED TO REMOVE AS MANY LOOSE THREADS AS POSSIBLE. RAYTEC WAS CONTAINED WITHIN ROI CPS, LLC CUSTOM PROCEDURE KIT 880092020, OR00092T, LOT 83111T.
Patient problems: Insufficient Information
MAUDE report 10838716 ↗MalfunctionNov 13, 2020Material Disintegration
RAYTEC GAUZE IS FRAYING AND LEAVING THREADS ON STERILE FIELD. THERE WAS PATIENT CONTACT. RAYTEC WAS REMOVED FROM THE STERILE FIELD AND A NEW PACK OF STERILE GAUZE WAS OPENED. TRIED TO REMOVE AS MANY LOOSE THREADS AS POSSIBLE. COMPONENT WAS USED IN ROI (B)(4) CUSTOMER PROCEDURE KIT NUMBER 880087014, GS00087N, LOT NUMBER 82828N.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10837065 ↗MalfunctionJul 15, 2020Component Missing; Component Missing
THE CUSTOMER REPORTED UPON OPENING THE PACKING, THEY FOUND ONLY 7 OF THE 10 GAUZE WERE IN THE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10279176 ↗MalfunctionFeb 11, 2020Nonstandard Device; Nonstandard Device
THE CUSTOMER REPORTED THAT THERE ARE 2 EXTRA RAYTEC. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9693426 ↗MalfunctionSep 13, 2019Component Missing; Component Missing
THE CUSTOMER REPORTED THAT ONE GAUZE WAS MISSING OF THE TEN THAT COME IN THE PACK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9030194 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page