Catheter, Straight
Gastroenterology, Urology · 21 CFR 876.5130
Recent MDR events
4,229 adverse event reports on file
- Unknown Intermittent CatheterJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05052
- Unknown Intermittent Rochester cathetersJul 27, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04948
- GENTLECATHJul 22, 2026InjuryUnomedical S.r.o.3005778470-2026-00783
- GENTLECATHJul 22, 2026InjuryUnomedical S.r.o.3005778470-2026-00784
- GENTLECATHJul 22, 2026InjuryUnomedical S.r.o.3005778470-2026-00782
- GENTLECATHJul 22, 2026InjuryUnomedical S.r.o.3005778470-2026-00785
- Magic3 Go Male Catheter with SureGripJul 20, 2026InjuryC.r. Bard Inc. (covington) -10182331018233-2026-04805
- MAGIC3 GO MALE COUDE CATHETER WITH SUREGRIPJul 14, 2026InjuryC.r. Bard Inc. (covington) -10182331018233-2026-04627
- CURE ULTRA MALE CATHETERJul 13, 2026MalfunctionConvatec1049092-2026-00189
- LUJA FEMALE URINARY INTERMITTENT DRAINAGE CATHETERJul 13, 2026InjuryColoplast A/s3006606901-2026-00006
Event type breakdown
Recalls
13 recall events for this product code
- C.R. Bard IncOpen, ClassifiedJun 8, 2023
Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
Z-1698-2023 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedJun 8, 2023
Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
Z-1699-2023 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedJun 8, 2023
Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
Z-1700-2023 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedJun 8, 2023
HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
Z-1701-2023 · View FDA record ↗ - C.R. Bard, Inc.TerminatedApr 4, 2018
HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3
Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
Z-1307-2018 · View FDA record ↗ - C.R. Bard, Inc.TerminatedApr 4, 2018
Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.
Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
Z-1308-2018 · View FDA record ↗ - C.R. Bard, Inc.TerminatedApr 4, 2018
Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers: 50612, 50614, 5061
Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
Z-1309-2018 · View FDA record ↗ - Cure Medical LLCTerminatedDec 16, 2014
Pediatric, 10Fr, Intermittent Urinary Catheters
Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric catheter but actually contain P10, French Size 10 pediatric catheters. Trying to use a P10 catheter for bladder drainage, where P8 catheters have been prescribed, may result in acute urinary retention; and, forced attempts to insert the French Size 10 catheter lead to urethral trauma.
Z-0496-2015 · View FDA record ↗ - Cure Medical LLCTerminatedOct 2, 2012
Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile
The firm initiated the product recall because labeling on some of the intermediate boxes of catheters identify the contents to be M16C, a coud-tip catheters while the actual contents are M16Fr male, 16Fr, straight-tip catheters with the pouch and the case box labeled as M16Fr male, 16Fr, straight-tip catheters.
Z-0004-2013 · View FDA record ↗ - Coloplast Manufacturing US, LLCTerminatedJun 3, 2011
SureCath Set with Accessories, Coloplast Corp.-MN 06093, Sterile EO., Manufacturer Coloplast -A/S 3050 Denmark.
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-2409-2011 · View FDA record ↗
Registered firms
174 firms currently registered for this product code
Greiner Mediscan Gmbh
KREMSMUNSTER Oberosterreich, AT
Hr Pharmaceuticals, Inc D/b/a Hr Healthcare
York, PA, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Coloplast A/s
HUMLEBAEK Hovedstaden, DK
Herotron E-beam Service Gmbh
Bitterfeld Saxony-Anhalt, DE
O&m Halyard, Inc.
Alpharetta, GA, US
Shaoxing Fuqing Health Products Co., Ltd.
Shaoxing Zhejiang, CN
Integral Medical Products Co., Ltd.
SHAOXING Zhejiang, CN
Coloplast Hungary Kft
NYIRBATOR Szabolcs-Szatmar-Bereg, HU
Convatec, Inc.
Greensboro, NC, US
Steritec Services, Llc
ATHENS, TX, US
Sterigenics Shanghai Eto Ltd.
Shanghai, CN
Chengdu Daxan Innovative Medical Tech. Co., Ltd.
chengdu Sichuan, CN
Changshu Rozer Sterilization Technology Co., Ltd.
Changshu Jiangsu, CN
Well Lead Medical Co. Ltd
GUANGZHOU Guangdong, CN
Conod Medical Shuyang Co., Ltd.
Shuyang Jiangsu, CN
Synergy Health Ede Bv
Venlo Limburg, NL
Convatec Limited, Gdc Building
Deeside Flintshire, GB
Hangzhou Jimushi Meditech Co., Ltd.
Hangzhou Zhejiang, CN
Compactcath, Inc
Palo Alto, CA, US
510(k) clearances
86 clearances for this product code
- ConvatecAug 5, 2026
K260737 · Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).
- Wellspect ABJul 17, 2026
K261658 · LoFric Origo Pro Coudé
- Coloplast A.S.Jul 7, 2026
K262045 · Luja Soft
- Hangzhou Jimushi Meditech Co., Ltd.Jun 24, 2026
K260394 · Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)
- Hollister IncorporatedMay 18, 2026
K253295 · Coude Sleeved IC; Coude Plus Sleeved IC
- Wellspect ABApr 24, 2026
K260999 · LoFric Elle Pro
- Convatec LimitedApr 1, 2026
K252943 · GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women
- HR HealthcareMar 12, 2026
K260502 · Liv Pre-lubricated Intermittent Catheter