FDA Device Intelligence
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Catheter, Coude

FDA product code EZC · Class 2 · Gastroenterology, Urology

311
Registered devices
10,519
Adverse events
11
Recalls
7
510(k) clearances

Devices with this code

Bardia — C. R. Bard, Inc.Bardex® Lubricath® Foley Catheter — C. R. Bard, Inc.SureStep™ Foley Tray System Bard®Lubricath® Foley Catheter — C. R. Bard, Inc.Bard® Foley Tray with Bard Hydrophilic-Coated Foley Catheter — C. R. Bard, Inc.Bardex® Lubricath® Hydrogel-Coated Foley Catheter Kit — C. R. Bard, Inc.SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter — C. R. Bard, Inc.Bard® Criticore® Foley Tray with Bardex® Lubricath® Temp Sensing Catheter — C. R. Bard, Inc.Bardex® Lubricath® Foley Catheter Ovoid Fluted Balloon — C. R. Bard, Inc.SureStep™ Foley Tray System with Bardex® Lubricath Temp Sensing Foley Catheter — C. R. Bard, Inc.Bardex® Lubricath® Foley Catheter Creevy Model — C. R. Bard, Inc.Bardex® Silicone Elastomer-Coated Foley Catheter Kit — C. R. Bard, Inc.SureStep™ Foley Tray System Bard® Lubricath® Foley Catheter Tray — C. R. Bard, Inc.Bardex® Lubricath® Foley Catheter Creevy Model — C. R. Bard, Inc.Sure Step™ Foley Tray System Bardex® Lubricath® Foley Catheter Tray — C. R. Bard, Inc.Bardex® Lubricath® Foley Catheter Coude Tip — C. R. Bard, Inc.Bard® Foley Catheter Silicone Coated — C. R. Bard, Inc.Bardex® Lubricath® Foley Catheter Coude Tip — C. R. Bard, Inc.OneCath — COMPACTCATH, INC.Bard® Lubricath® Foley Catheter — C. R. Bard, Inc.Bard® Urine Meter Foley Catheter Tray With Bardex® Lubricath® Foley Catheter — C. R. Bard, Inc.Bard® Foley Tray with Bardex® Lubricath® Foley Catheter — C. R. Bard, Inc.SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter — C. R. Bard, Inc.Bardex® Councill Model Foley Catheter — C. R. Bard, Inc.RUSCH — TELEFLEX INCORPORATED

Recent recalls

DateFirmReason
2026-06-25C.R. Bard IncDue to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
2025-06-03C.R. Bard IncCather packaging may contain the incorrect French size.
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.
2021-08-05C.R. Bard IncThere is potential for packaging defects that may impact the sterile barrier.
2017-12-13C.R. Bard, Inc.Foley Catheter with Incorrect Retainer Cap Print

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.