Marker, Skin
FDA adverse event reports and recall history for marker, skin (product code FZZ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 185
- Deaths
- 0
- Injuries
- 51
- Malfunctions
- 119
Reports per year
Source: FDA adverse event reports by year received, 2009–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2013-08-02TerminatedComponent change control
Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement; available in nonsterile configuration.
PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers, becuase they were inadvertently mislabeled as PN STER-VIS Sterile Skin Marker Pen with Labels and Flex Ruter.
- 2013-03-29TerminatedDevice Design
Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.
Dual Tip Marker has inconsistent ink flow on the black permanent ink side.
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