Home › Device types › GBM
Catheter, Urethral
FDA product code GBM · Class 2 · Gastroenterology, Urology
725
Registered devices
2,616
Adverse events
18
Recalls
71
510(k) clearances
Devices with this code
GENTLECATH AIR — CONVATEC, PURCHASING DEPARTMENTBD Intermittent — Hangzhou Bever Medical Devices Co., Ltd.McKesson — MCKESSON MEDICAL-SURGICAL INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.VaPro — HOLLISTER INCORPORATEDActreen® — B. BRAUN MEDICAL INC.InstantCath — HOLLISTER INCORPORATEDApogee — HOLLISTER INCORPORATEDVaPro Plus — HOLLISTER INCORPORATEDUreteral Catheter — BOSTON SCIENTIFIC CORPORATIONGENTLECATH AIR — CONVATEC, PURCHASING DEPARTMENTApogee IC — HOLLISTER INCORPORATEDMcKesson — MCKESSON MEDICAL-SURGICAL INC.BeneCath® — Hangzhou Jimushi Meditech Co., Ltd.TruCath — HR PHARMACEUTICALS INC.VaPro — HOLLISTER INCORPORATEDVaPro Plus Pocket — HOLLISTER INCORPORATEDBard® Center Entry Foley Tray with Bardex® All Silicone Foley Catheter — C. R. Bard, Inc.McKesson — MCKESSON MEDICAL-SURGICAL INC.O'Neil Intermittent Urinary Catheter — GO MEDICAL INDUSTRIES PTY. LTD.MTG Female Intermittent Catheter, Straight-tip — MEDICAL TECHNOLOGIES OF GEORGIA, INC.BD Intermittent — Hangzhou Bever Medical Devices Co., Ltd.GENTLECATH — CONVATEC, PURCHASING DEPARTMENTMcKesson — MCKESSON MEDICAL-SURGICAL INC.
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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