Home › Device types › EZL
Catheter, Retention Type, Balloon
FDA product code EZL · Class 2 · Gastroenterology, Urology
1,467
Registered devices
9,552
Adverse events
85
Recalls
131
510(k) clearances
Devices with this code
2Way Foley Balloon Catheter — AP MDS Co., Ltd.Disposable Silicone Foley Catheter — Guangdong Baihe Medical Technology Co., Ltd.Dover — Cardinal Health, Inc.Porges Coloplast — Coloplast A/SRUSCH — TELEFLEX INCORPORATEDAll Silicone Foley Catheter — Well Lead Medical Co.,LtdMedline — MEDLINE INDUSTRIES, INC.TraumaGuard Intra-abdominal Pressure-Sensing System — SENTINEL MEDICAL TECHNOLOGIESAquaFlate — HR PHARMACEUTICALS INC.NURSE ASSIST — NURSE ASSIST, INC.RUSCH — TELEFLEX INCORPORATEDRUSCH — TELEFLEX INCORPORATEDDover — Cardinal Health 200, LLCMcKesson — MCKESSON MEDICAL-SURGICAL INC.Bardex® Lubri-Sil® All-Silicone Foley Catheter — C. R. Bard, Inc.TruCath — HR PHARMACEUTICALS INC.Dover — Cardinal Health 200, LLCCovidien AG — DEGANIA SILICONE LTDAll Silicone Foley Catheter — Well Lead Medical Co.,LtdFoley Catheter — GERI-GENTLE CORPORATIONRUSCH — TELEFLEX INCORPORATEDBard® Urine Meter Tray with Bardex® All Silicone Foley Catheter — C. R. Bard, Inc.Porges Coloplast — Coloplast A/SDover — Cardinal Health 200, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-25 | C.R. Bard Inc | Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. |
| 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. |
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