Home › Device types › EZL
Catheter, Retention Type, Balloon
FDA product code EZL · Class 2 · Gastroenterology, Urology
1,451
Registered devices
9,331
Adverse events
84
Recalls
129
510(k) clearances
Devices with this code
Bardex® Lubri-Sil® All-Silicone Foley Catheter — C. R. Bard, Inc.Dover — Cardinal Health, Inc.ClearTract — SILQ Technologies CorporationBard Vertus Foley Catheter — C. R. Bard, Inc.Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter — C. R. Bard, Inc.Bardex® All-Silicone Temperature-Sensing Foley Catheter — C. R. Bard, Inc.Bard® Pediatric Urine Meter Foley Tray, Lubri-Sil® All-Silicone Foley Catheter — C. R. Bard, Inc.Dover — Cardinal Health 200, LLCFoley Catheters — Dynarex CorporationSureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter — C. R. Bard, Inc.SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter — C. R. Bard, Inc.AMSure® Silicone Coated Latex Foley Catheter — AMSINO INTERNATIONAL, INC.AMSure® 100% Silicone Foley Catheter — AMSINO INTERNATIONAL, INC.Silicone 2-way Foley Balloon Catheter (Standard Balloon) — FORTUNE MEDICAL INSTRUMENT CORP.Dover — Cardinal Health, Inc.McKesson — MCKESSON MEDICAL-SURGICAL INC.Bard® Foley Tray With Lubri-Sil® All-Silicone Foley Catheter — C. R. Bard, Inc.All Silicone Foley Catheter — Well Lead Medical Co.,LtdSurgyco — Surgyco LLCAll Silicone Foley Catheter — Well Lead Medical Co.,LtdLubri-Sil® I.C. Complete Care® All-Silicone Foley Catheter Tray — C. R. Bard, Inc.AMSure® Silicone Coated Latex Foley Catheter — AMSINO INTERNATIONAL, INC.Silicone 2-way Foley Balloon Catheter (Standard Balloon) — FORTUNE MEDICAL INSTRUMENT CORP.AMSure ® Hydrophilic Latex Foley Catheters — AMSINO INTERNATIONAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-23 | C.R. Bard Inc | Due to stain present on the surface of affected foley catheters. |
| 2025-06-18 | C.R. Bard Inc | Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pai |
| 2024-12-02 | Coloplast Manufacturing US, LLC | A possible sterility issue was detected in Coloplast's facility on some Coloplast products. |
| 2024-12-02 | Coloplast Manufacturing US, LLC | A possible sterility issue was detected in Coloplast's facility on some Coloplast products. |
| 2023-12-04 | Cardinal Health 200, LLC | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2023-11-06 | Nurse Assist, LLC | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, wh |
| 2021-08-05 | C.R. Bard Inc | There is potential for packaging defects that may impact the sterile barrier. |
| 2021-08-05 | C.R. Bard Inc | There is potential for packaging defects that may impact the sterile barrier. |
| 2021-08-05 | C.R. Bard Inc | There is potential for packaging defects that may impact the sterile barrier. |
| 2021-08-05 | C.R. Bard Inc | There is potential for packaging defects that may impact the sterile barrier. |
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