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MJCClass 2

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 corpus and the live FDA recall database.

Total reports
16,553
Deaths
2
Injuries
649
Malfunctions
15,893

Reports per year

12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Recent recalls

  • 2026-09-04Open, ClassifiedUnder Investigation by firm

    Products that contain the Pericare Wipes: *Bardex I.C. Complete Care Foley Catheter Tray REF: 300316A UDI codes: 00801741024344 10801741024341 *Bardex I.C. Complete Care Foley Catheter Tray and Urine Meter REF: 303314A 303316A 303318A UDI code: 00801741024252 10801741024259 00801741024269 10801741024266 00801741024276 10801741024273 *SureStep" Foley Tray System Bardex IC Complete Care REF: A300314A UDI codes: 00801741073724 10801741073721 REF: A300314AC (Canada Only) UDI-DI code: 00801741143243 *SureStep" Foley Tray System Bardex IC Complete Care REF: A300316A UDI code: 00801741073731 10801741073738 *SureStep" Foley Tray System Bardex IC Complete Care REF: A300318A UDI code: 00801741073748 10801741073745 *SureStep" Foley Tray System Bardex IC Complete Care REF: A303314A A303316A A303318A UDI code: 00801741073786 10801741073783 00801741073793 10801741073790 00801741073809 10801741073806 *SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A303414A UDI code: 00801741073816 10801741073813 *(416A)SureStep" Foley Tray System Bardex IC Complete Care (714A/716A/718A)SureStep" Foley Tray System Bardex IC Complete Care (914)SureStep" Foley Tray System REF: A304716A A304714A A304716A A304718A UDI code: 00801741104206 10801741104203 00801741104268 10801741104265 00801741104299 10801741104296 00801741100376 10801741100373 *SureStep" Foley Tray System Bardex IC Complete Care REF: A319416A UDI code: 00801741100307 10801741100304 *SureStep" Foley Tray System Bardex I.C. Complete Care Foley Catheter REF: A319416AM UDI code: 00801741073861 10801741073868 *SureStep" Foley Tray System Bardex IC Complete Care REF: A319418A UDI code: 00801741100314 10801741100311 SureStep" Foley Tray System Bardex IC Complete Care REF: A903316A UDI code: 00801741096600 10801741096607 ***** SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A300414A UDI code: 00801741073755 10801741073752 SureStep" Foley Tray System Bardex I.C. Complete Care Foley Catheter REF: A319414AM UDI code: 00801741073854 10801741073851 SureStep" Foley Tray System Bardex I.C. Complete Care Foley Catheter REF: A319418AM UDI code: 00801741073878 10801741073875 SureStep" Foley Tray System Bardex IC Complete Care REF: A903318A UDI code: 00801741104657 10801741104654 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.

    Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

  • 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.

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