NZUClass 1
Collector, Urine, Powered, Non Indwelling Catheter
FDA adverse event reports and recall history for collector, urine, powered, non indwelling catheter (product code NZU), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 3,860
- Deaths
- 11
- Injuries
- 1,883
- Malfunctions
- 1,964
Reports per year
116
2518
5019
15320
60521
51622
24123
14324
1,13325
99326
Source: FDA adverse event reports by year received, 2016–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2023-11-21Open, ClassifiedProcess change control
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label
Monitor collector, urine, powered, non indwelling catheter automatically
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