Stool, Operating-Room
FDA adverse event reports and recall history for stool, operating-room (product code FZM), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 389
- Deaths
- 0
- Injuries
- 2
- Malfunctions
- 385
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- Open, ClassifiedUnder Investigation by firm
Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
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