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Catheter, Urethral
FDA product code GBM · Class 2 · Gastroenterology, Urology
739
Registered devices
2,601
Adverse events
18
Recalls
71
510(k) clearances
Devices with this code
SpeediCath Standard — Coloplast A/SMcKesson — MCKESSON MEDICAL-SURGICAL INC.Apogee IC — HOLLISTER INCORPORATEDURI-CATH — UTAH MEDICAL PRODUCTS, INC.TruCath — HR PHARMACEUTICALS INC.Bardex® All-Silicone Foley Catheter — C. R. Bard, Inc.URI-CATH — UTAH MEDICAL PRODUCTS, INC.BeneCath® — Hangzhou Jimushi Meditech Co., Ltd.SpeediCath Standard — Coloplast A/SBeneCath® — Hangzhou Jimushi Meditech Co., Ltd.VaPro Plus Pocket — HOLLISTER INCORPORATEDGENTLECATH AIR — CONVATEC, PURCHASING DEPARTMENTMcKesson — MCKESSON MEDICAL-SURGICAL INC.V. Mueller — CAREFUSION 2200, INCUreteral Catheter — BOSTON SCIENTIFIC CORPORATIONBeneCath® — Hangzhou Jimushi Meditech Co., Ltd.TELEFLEX — TELEFLEX INCORPORATEDBeneCath® — Hangzhou Jimushi Meditech Co., Ltd.Actreen® — B. BRAUN MEDICAL INC.Apogee IC — HOLLISTER INCORPORATEDTruCath Oasis — HR PHARMACEUTICALS INC.Actreen® — B. BRAUN MEDICAL INC.MTG Intermittent Catheter, Straight-tip — MEDICAL TECHNOLOGIES OF GEORGIA, INC.GENTLECATH GLIDE — CONVATEC, PURCHASING DEPARTMENT
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-14 | Hollister Ulc | Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might l |
| 2025-11-29 | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. | Labeling error, Incorrect expiration date |
| 2023-12-04 | Cardinal Health 200, LLC | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2021-08-05 | C.R. Bard Inc | There is potential for packaging defects that may impact the sterile barrier. |
| 2018-03-15 | Teleflex Medical Europe Ltd | These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex |
| 2011-04-21 | Coloplast Manufacturing US, LLC | Coloplast has initiated a recall on SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies because they contain Iodine prep pads which may |
| 2008-07-17 | Apogee Medical, Inc | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the produc |
| 2008-07-17 | Apogee Medical, Inc | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the produc |
| 2008-07-17 | Apogee Medical, Inc | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the produc |
| 2008-07-17 | Apogee Medical, Inc | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the produc |
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