Catheter, Urological (Antimicrobial) And Accessories
FDA adverse event reports and recall history for catheter, urological (antimicrobial) and accessories (product code MJC), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 16,158
- Deaths
- 1
- Injuries
- 630
- Malfunctions
- 15,518
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-09-18Open, ClassifiedLabeling mix-ups
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
- 2025-09-18Open, ClassifiedLabeling mix-ups
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
- 2025-09-18Open, ClassifiedLabeling mix-ups
SureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray, REF: A942216
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
- 2024-06-18Open, ClassifiedComponent design/selection
Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 350 ml Urine Meter, 16 Fr, Catalog #319416AM. Intended for use in the drainage and/or collection and/or measurement of urine.
Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
- 2021-09-23Open, ClassifiedPackaging change control
Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-23Open, ClassifiedPackaging change control
Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-23Open, ClassifiedPackaging change control
Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-23Open, ClassifiedPackaging change control
Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-23Open, ClassifiedPackaging change control
Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-23Open, ClassifiedPackaging change control
Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
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