Catheter, Urological
FDA adverse event reports and recall history for catheter, urological (product code KOD), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 17,287
- Deaths
- 30
- Injuries
- 2,881
- Malfunctions
- 13,977
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-09-04Open, ClassifiedUnder Investigation by firm
Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08 PEDINTS10 UDI code: 00801741183300 10801741183307 00801741183218 10801741183215 00801741183232 10801741183239 00801741183225 10801741183222 00801741183249 10801741183246 00801741183263 10801741183260 00801741183270 10801741183277 00801741183287 10801741183284 Preamendment REF: INTL14 INTL15 INTL16 INTP14 UDI code: 00801741183164 10801741183161 00801741183171 10801741183178 00801741183188 10801741183185 00801741183294 10801741183291 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- 2025-07-03Open, ClassifiedUnder Investigation by firm
BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120
Cather packaging may contain the incorrect French size.
- 2025-07-03Open, ClassifiedUnder Investigation by firm
BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316
Cather packaging may contain the incorrect French size.
- 2024-02-16Open, ClassifiedNonconforming Material/Component
Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY, 14 FR (4.7 MM), 10 CC WATER SYRINGE
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- 2022-11-11Open, ClassifiedNonconforming Material/Component
Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
Product may not be sterile
- 2015-09-03TerminatedUnknown/Undetermined by firm
Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermittent Urinary Catheter
Potential breach of the sterile barrier packaging.
- 2015-08-14TerminatedUnknown/Undetermined by firm
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610. Intermittent catheter.
Potential breach of the sterile barrier packaging.
- 2015-08-14TerminatedUnknown/Undetermined by firm
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612. Intermittent catheter.
Potential breach of the sterile barrier packaging.
- 2015-08-14TerminatedUnknown/Undetermined by firm
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614. Intermittent catheter.
Potential breach of the sterile barrier packaging.
- 2015-08-14TerminatedUnknown/Undetermined by firm
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box), Product Code 51616. Intermittent catheter.
Potential breach of the sterile barrier packaging.
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