Catheter, Urethral
FDA adverse event reports and recall history for catheter, urethral (product code GBM), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,589
- Deaths
- 4
- Injuries
- 683
- Malfunctions
- 1,895
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-01-12Open, ClassifiedLabeling Change Control
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Labeling error, Incorrect expiration date
- 2024-02-16Open, ClassifiedNonconforming Material/Component
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.
- 2021-09-23Open, ClassifiedPackaging change control
Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2018-04-12TerminatedEmployee error
Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 (c) 650704160 551316 Product Usage: RUSCH Simplastic Suprapubic Puncture Instruments are indicated for emergency suprapubic drainage of the bladder.
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.
- 2011-06-03TerminatedIncorrect or no expiration date
SpeediCath , SpeediCath with Accessories Coloplast Corp -MN, Sterile R, Manufacturer Coloplast -A/S 3050 Denmark 284821 1400 SpeediCath, acc CH10 Male 284831 1400 SpeediCath, acc CH12 Male 284841 1400 SpeediCath, acc CH14 Male 284851 1400 SpeediCath, acc CH16 Male 284861 1400 SpeediCath, acc CH18 Male 284811 1400 SpeediCath, acc CH8 Male 285011 1400 SpeediCath,acc CH10 Female 285021 1400 SpeediCath,acc CH12 Female 285031 1400 SpeediCath,acc CH14 Female 285041 1400 SpeediCath,acc CH16 Female 284991 1400 SpeediCath,acc CH6 Female 285001 1400 SpeediCath,acc CH8 Female The SpeediCath catheter is indicated for use by patients with chronic urine retention and patients with post void a residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urin to drain. The insertion supplies provided are to be used to insert the catheter using sterile technique.
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
- 2008-09-21TerminatedPackaging process control
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 to drain urine from the bladder.
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.
- 2008-09-21TerminatedPackaging process control
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 to drain urine from the bladder.
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.
- 2008-09-21TerminatedPackaging process control
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 to drain urine from the bladder.
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.
- 2008-09-21TerminatedPackaging process control
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 device designed to drain urine from the bladder.
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.
- 2008-09-21TerminatedPackaging process control
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 device designed to drain urine from the bladder.
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.
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