FDA Device Intelligence
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Catheter, Urological (Antimicrobial) And Accessories

FDA product code MJC · Class 2 · Gastroenterology, Urology

571
Registered devices
16,326
Adverse events
22
Recalls
10
510(k) clearances

Devices with this code

Bardex® I.C. Temperature-Sensing Foley Catheter — C. R. Bard, Inc.Latex Foley Catheter — Well Lead Medical Co.,LtdBardex® I.C. Complete Care® Foley Catheter Tray and Urine Meter — C. R. Bard, Inc.Latex Foley Catheter — Well Lead Medical Co.,LtdBardex® I.C. Complete Care® Foley Catheter Tray With Urine Meter — C. R. Bard, Inc.SureStep™ Foley Tray System Bardex® IC Complete Care® — C. R. Bard, Inc.Latex Foley Catheter — Well Lead Medical Co.,LtdBardex® I.C. Tiemann Model Coude Tip Foley Catheter — C. R. Bard, Inc.Latex Foley Catheter — Well Lead Medical Co.,LtdLatex Foley Catheter — Well Lead Medical Co.,LtdBardex® I.C. Foley Catheter — C. R. Bard, Inc.Bardex® I.C. Short Tip Foley Catheter — C. R. Bard, Inc.SureStep™ Foley Tray System Lubri-Sil® I.C. Complete Care® Temp Sensing Foley — C. R. Bard, Inc.Bardex® I.C. Foley Catheter — C. R. Bard, Inc.Bardex® I.C. Complete Care® Temp-Sensing Foley Catheter Tray With Urine Meter — C. R. Bard, Inc.Bardex® I.C. Complete Care® Foley Catheter Tray and Urine Meter — C. R. Bard, Inc.SureStep Foley Tray System — C. R. Bard, Inc.Bardex® I.C. Complete Care® Foley Catheter Tray and Urine Meter — C. R. Bard, Inc.Latex Foley Catheter — Well Lead Medical Co.,LtdLatex Foley Catheter — Well Lead Medical Co.,LtdBardex® I.C. Foley Catheter — C. R. Bard, Inc.Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley Catheter — C. R. Bard, Inc.SureStep™ Foley Tray System Bardex® IC Complete Care® — C. R. Bard, Inc.Latex Foley Catheter — Well Lead Medical Co.,Ltd

Recent recalls

DateFirmReason
2025-07-17C.R. Bard IncFoley 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
2025-07-17C.R. Bard IncFoley 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
2025-07-17C.R. Bard IncFoley 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
2024-05-09C.R. Bard IncSome of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
2021-08-05C.R. Bard IncThere is potential for packaging defects that may impact the sterile barrier.
2021-08-05C.R. Bard IncThere is potential for packaging defects that may impact the sterile barrier.
2021-08-05C.R. Bard IncThere is potential for packaging defects that may impact the sterile barrier.
2021-08-05C.R. Bard IncThere is potential for packaging defects that may impact the sterile barrier.
2021-08-05C.R. Bard IncThere is potential for packaging defects that may impact the sterile barrier.
2021-08-05C.R. Bard IncThere is potential for packaging defects that may impact the sterile barrier.

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