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/AEMS corpus and the live FDA recall database.
- Total reports
- 3,704
- Deaths
- 11
- Injuries
- 1,844
- Malfunctions
- 1,847
Reports per year
116
2518
5019
15320
60521
51622
24123
14324
1,13325
83726
Source: FDA adverse event reports by year received, 2016–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition 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
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.