Catheter, Urethral
Gastroenterology, Urology · 21 CFR 876.5130
Recent MDR events
2,601 adverse event reports on file
- OnliJul 28, 2026InjuryHollister Incorporated9616668-2026-00005
- DoverJul 27, 2026MalfunctionCardinal Health 200, Llc1423537-2026-00243
- VaPro PocketJul 27, 2026InjuryHollister Incorporated9616668-2026-00006
- Bardex® All-Silicone Foley CatheterJul 27, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04931
- SPEEDICATH STANDARD URINARY INTERMITTENT DRAINAGE CATHETERJul 22, 2026InjuryColoplast A/s3015131144-2026-00004
- GENTLECATHJul 20, 2026MalfunctionUnomedical S.r.o.3005778470-2026-00778
- BARDEX® ALL-SILICONE FOLEY CATHETERJul 12, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04479
- BARDEX® ALL-SILICONE FOLEY CATHETERJul 12, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04534
- BARDEX® ALL-SILICONE FOLEY CATHETERJul 12, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04544
- BARDEX® ALL-SILICONE FOLEY CATHETERJul 12, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04550
Event type breakdown
Recalls
17 recall events for this product code
- HANGZHOU BEVER MEDICAL DEVICES CO., LTD.Open, ClassifiedJan 12, 2026
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female
Labeling error, Incorrect expiration date
Z-1061-2026 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedFeb 16, 2024
Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Z-1051-2024 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedSep 23, 2021
Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
Z-2533-2021 · View FDA record ↗ - Teleflex Medical Europe LtdTerminatedApr 12, 2018
Simplastic Suprapubic Puncture Instruments:
These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
Z-1369-2018 · View FDA record ↗ - Coloplast Manufacturing US, LLCTerminatedJun 3, 2011
SpeediCath , SpeediCath with Accessories
Coloplast has initiated a recall on SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies because they contain Iodine prep pads which may expire before the overall product expiration date. SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies are both packaged with a set of accessories which includes Iodine prep pads. The Iodine prep pads included i
Z-2410-2011 · View FDA record ↗ - Apogee Medical, IncTerminatedSep 21, 2008
Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed
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 product could be compromised.
Z-2390-2008 · View FDA record ↗ - Apogee Medical, IncTerminatedSep 21, 2008
Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No. 1018, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed
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 product could be compromised.
Z-2391-2008 · View FDA record ↗ - Apogee Medical, IncTerminatedSep 21, 2008
Apogee Intermittent Catheter, 10 Fr 15", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed
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 product could be compromised.
Z-2392-2008 · View FDA record ↗ - Apogee Medical, IncTerminatedSep 21, 2008
Apogee Intermittent Catheter with Coude tip, 12 Fr 16", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence
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 product could be compromised.
Z-2393-2008 · View FDA record ↗ - Apogee Medical, IncTerminatedSep 21, 2008
Apogee Intermittent Catheter with Coude tip, 14 Fr 16", Catalog/Ref No.1066, Sterile, Latex free. The device is intended to be used as a urinary incontinence d
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 product could be compromised.
Z-2394-2008 · View FDA record ↗
Registered firms
162 firms currently registered for this product code
Hollister Incorporated
LIBERTYVILLE, IL, US
Greiner Mediscan Gmbh
KREMSMUNSTER Oberosterreich, AT
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Synergy Health Ede Bv
Venlo Limburg, NL
Coloplast A/s
HUMLEBAEK Hovedstaden, DK
Bgs Beta-gamma-service Gmbh & Co Kg
Wiehl North Rhine-Westphalia, DE
Boston Scientific Limited
GALWAY, IE
Sterigenics U.s., Llc
Charlotte, NC, US
Hollister Ulc
REHINS BALLINA Mayo, IE
Cardinal Health (kenmex Medical Specialties)
TIJUANA Baja California, MX
Hollister, Inc.
Mount Juliet, TN, US
Teleflex Medical Llc
Morrisville, NC, US
Cook Incorporated
Spencer, IN, US
Synergy Health Ede Bv
Venlo Limburg, NL
Cook Incorporated
Bloomington, IN, US
Hollister Services Bv
Roosendaal Noord-Brabant, NL
Convatec, Inc.
Greensboro, NC, US
Hangzhou Bever Medical Devices Co., Ltd.
Hangzhou Zhejiang, CN
Boston Scientific Corporation
Saint Paul, MN, US
Rr Donnelley-supply Chain Solutions
Plover, WI, US
Coloplast Costa Rica Sa
La Lima, Guadalupe Cartago, CR
510(k) clearances
71 clearances for this product code
- Well Lead Medical Co., Ltd.Mar 5, 2025
K241734 · Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
- Convatec LimitedJun 22, 2022
K213283 · GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
- Hollister IncorporatedJan 27, 2022
K211436 · Intermittent Catheter (Not Finalized)
- ColoplastNov 13, 2020
K200820 · SpeediCath Compact Set
- ColoplastNov 2, 2020
K192904 · SpeediCath Compact Set
- ColoplastJul 30, 2020
K200142 · SpeediCath Soft
- Hangzhou Jimushi Meditech Co., Ltd.Jun 1, 2020
K200134 · Jimushi Sterile Urethral Catheter for single use
- Hakki Medical Technologies, Inc.May 21, 2020
K191512 · LotusCatheter (Lotus No Balloon Catheter)