Bardex Lubricath Foley Catheter TrayRecalls & reported problems across all models

We found 3 models of Bardex Lubricath Foley Catheter Tray by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Sep 18, 2017 and Sep 16, 2025 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (2 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Bardex Lubricath Foley Catheter Tray recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 25, 2026Class IIOpen, Classified

   Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

   Z-3114-2026 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗

Most reported Bardex Lubricath Foley Catheter Tray problems

Bardex Lubricath Foley Catheter Tray models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bardex® Lubricath® Foley Catheter Tray 899916

  CATHETER, COUDE
  1 recall6 reports
• Bardex® Lubricath® Foley Catheter Tray 899914

  CATHETER, COUDE
  1 recall5 reports
• Bardex® Lubricath® Foley Catheter Tray 899918

  CATHETER, COUDE
  1 recall0 reports

Recent Bardex Lubricath Foley Catheter Tray adverse event reports

The 11 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT, GENITAL CLEANING BEGAN WITH A CLOSED-CIRCUIT 14FR BLADDER CATHETER, AND WHEN THE COVER WAS REMOVED, THE CATHETER WAS MISSING IN THE FOLEY TRAY. THIS OCCURRED DURING THE INTRAOPERATIVE PERIOD. 14FR FOLEY CATHETER WITH A SEPARATE COLLECTION BAG WAS REQUESTED FROM THE SUB-CENTRAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062386 ↗
• MalfunctionMay 7, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE INDIVIDUAL PACKAGING BAG OF TWO PIECES OF THE PRODUCT WERE NOT SEALED LIKE THE OTHERS IN THE FOLEY TRAY. SINCE THE PRODUCTS WERE SUPPOSED TO BE STERILIZED AND THE BAGS WERE OPEN, THE PRODUCTS CANNOT BE USED IN HOSPITAL/PATIENTS DUE TO THE RISK OF CLINICAL COMPLICATIONS AND WERE KEPT AT DISTRIBUTOR'S WAREHOUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316104 ↗
• MalfunctionApr 2, 2022Illegible Information; Illegible Information

  IT WAS REPORTED THAT NURSE DISCOVERED THAT THE FOLEY CATHETER KIT WHICH WAS ABOUT TO USE ON A PATIENT WAS MADE OF LATEX. STATED THAT THE NURSE DID NOT USE THIS PRODUCT ON THE PATIENT, BUT NOTABLY THE PACKAGING DID NOT IDENTIFY THAT THIS PRODUCT CONTAINED LATEX UNTIL AFTER THE STERILE PACKAGING WAS OPENED AND ONLY THEN IT WAS LISTED IN SMALL PRINT ON A PAPER PRODUCT INSERT. GIVEN THE PREVALENCE OF SERIOUS LATEX ALLERGIES, THIS PRODUCT DID NOT FEEL SAFE TO USE IN THE HOSPITAL. AND THERE WAS ANOTHER PRODUCT THEY FOUND THAT APPEARED TO HAVE IDENTICAL PACKAGING BUT WAS MADE OF SILICONE INSTEAD. THE FOLEY CATHETER KIT SEEMED SAFE FOR HOSPITAL USE, WHEREAS THE BARD LUBRICATH FOLEY CATHETER TRAY KIT CONTAINS LATEX. THE VISUAL APPEARANCE OF THE LATEX PACKAGE AND THE LATEX FREE PACKAGE WERE VERY SIMILAR, AND IT WAS EASY TO NOT NOTICE THE DIFFERENCE. IT WOULD BE MUCH BETTER IF THE PACKAGING WAS A DIFFERENT COLOR OR HAD A MUCH MORE PROMINENT LATEX WARNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13992238 ↗
• MalfunctionDec 29, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE NURSES FELT THAT THEY WERE HAVING A DIFFICULT TIME IN TELLING WHEN THE URINE WAS DONE FLOWING IN THE STRAIGHT CATHETER KIT WITH THE BAG ATTACHED, COMPARED TO WHEN THE KIT HAD A SEPARATE COLLECTION CONTAINER. THEY CONFIRMED HAVING THIS PROBLEM, AND USUALLY THEY JUST MANIPULATE THE BAG BY LIFTING IT UP TO SEE IF IT WAS STILL DRIPPING OR NOT. NURSES REPORTED THAT WITH A 16FR TRAY CONTAINING A REGULAR FOLEY BAG WHEN THEY OPEN THE CORNERS OF THE STERILE FIELD, THE FIRST STERILE DRAPE NOT FENESTRATED WAS PLACED ABOVE THE GLOVES, SO THEY COULD NOT REMOVE IT STERILELY TO USE IT TO EXTEND THE STERILE FIELD. ADDITIONALLY, THERE WAS SIGNIFICANT CONCERN WITH THE SIZE OF THE STERILE FIELD AND NOT HAVING ROOM TO PULL OUT THE TRAY TO ACCESS THE BAG AND CATHETER AND ASEPTICALLY LAY THE CATHETER INTO THE LUBRICATING GEL. THEY WERE ONLY USING METER TRAYS, AND THEY HAD ALL SURESTEP TRAYS, SO THIS WAS A SMALLER SQUARE TRAY WITH A BAG THAT SEEMED A BIT DIFFERENT. THEY FELT IT TO BE HARDER TO MANIPULATE STERILELY. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2021, THE CUSTOMER REPORTED THAT THERE WASN'T AN ISSUE WITH THE PRODUCT DRAINING BUT JUST A CONCERN FROM NURSES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114566 ↗
• MalfunctionDec 20, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE NURSES FELT THEY THAT WERE HAVING DIFFICULT TIME IN TELLING WHEN THE URINE WAS DONE FLOWING IN THE STRAIGHT CATHETER KIT WITH THE BAG ATTACHED, COMPARED TO WHEN THE KIT HAD A SEPARATE COLLECTION CONTAINER. THEY CONFIRMED HAVING THIS PROBLEM AND USUALLY THEY JUST MANIPULATE THE BAG BY LIFTING IT UP TO SEE IF IT WAS STILL DRIPPING OR NOT. NURSES REPORTED THAT WITH 16FR TRAY CONTAINING A REGULAR FOLEY BAG WHEN THEY OPEN THE CORNERS OF THE STERILE FIELD, THE FIRST STERILE DRAPE NOT FENESTRATED WAS PLACED ABOVE THE GLOVES, SO THEY COULD NOT REMOVE IT STERILELY TO USE IT TO EXTEND THE STERILE FIELD. ADDITIONALLY, THERE WAS SIGNIFICANT CONCERN WITH THE SIZE OF THE STERILE FIELD AND NOT HAVING ROOM TO PULL OUT THE TRAY TO ACCESS THE BAG AND CATHETER AND ASEPTICALLY LAY THE CATHETER INTO THE LUBRICATING GEL. THEY WERE ONLY USING METER TRAYS AND THEY HAD ALL SURESTEP TRAYS, SO THIS WAS A SMALLER SQUARE TRAY WITH A BAG THAT SEEMED A BIT DIFFERENT. THEY FELT IT TO BE HARDER TO MANIPULATE STERILELY. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 08DEC2021, CUSTOMER REPORTED THAT THERE WASN¿T AN ISSUE WITH THE PRODUCT DRAINING BUT JUST A CONCERN FROM NURSES THAT THEY C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048987 ↗
• MalfunctionDec 10, 2021Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PRIMARY PACKAGING OF THE FOLEY TRAY ARRIVED COMPLETELY OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12981420 ↗
• InjuryNov 30, 2020Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE INDWELLING CATHETERS ON 4 VETERANS HAD TO BE CHANGED WITHIN TWO DAYS. ALTHOUGH THE INDWELLING CATHETERS WERE ABLE TO BE FLUSHED, THE CATHETERS WERE NOT DRAINING URINE. HENCE, THE VETERAN¿S BLADDER WAS SCANNED TO CHECK IF THERE WAS ANY URINE PRESENT IN THE BLADDER. THE BLADDER SCAN REVEALED 900 ML OF URINE WITH THE FOLEY IN PLACE. HENCE, THE CATHETER WAS CHANGED, AND THE FOLEY HAS ONCE AGAIN STOPPED DRAINING. IT WAS ALSO REPORTED THAT THE URINE WAS COMING OUT AROUND THE CATHETER. THE BALLOON OF THE CATHETER WAS ASSESSED, AND IT WAS CONFIRMED THAT THE CORRECT AMOUNT OF NORMAL SALINE WAS HELD WITHIN THE BALLOON. IT WAS FURTHER REPORTED THAT THERE WERE ISSUES WITH THE INDWELLING CATHETERS ON FOUR UNITS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Urinary Retention

  MAUDE report 10919276 ↗
• InjurySep 1, 2020Biocompatibility; Device Markings/Labelling Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT WITH LATEX ALLERGY HAD CATHETER FROM FOLEY KIT USED AND DEVELOPED AN ALLERGIC REACTION. PACKAGING DOES NOT MAKE IT VERY EVIDENT THAT PRODUCT CONTAINS LATEX. FOLEY HAS AN ASTERISK WHICH WAS DEFINED IN VERY SMALL PRINT ON THE SIDE AS CONTAINING LATEX. ON THE PACKAGING OF THE DEVICE, THERE ARE TWO SMALL ASTERISKS NEXT TO THE CATHETER, BUT THE LEGEND FOR THE WHAT THAT MEANS IT IS IN SMALL PRINT ON THE SIDE OF THE PACKAGE. PATIENT CONDUCTED PHYSICIANS OFFICE POST-OPERATIVE DAY WITH 3 COMPLAINTS OF IRRITATION FROM CATHETER AND THINKING THE PATIENT MAY HAVE YEAST INFECTION. PATIENT SEEN BY MEDICAL DOCTOR IN THE OFFICE WHERE SWELLING AND ERYTHEMA ON BILATERAL LABIA MINOR AND MAJORA WAS NOTED. CATHETER WAS REMOVED AND PATIENT COMPLETED VOIDING TRIAL SUCCESSFULLY. PATIENT WAS PRESCRIBED TRIAMCINOLONE CREAM TO THE VULVA THREE TIMES IN A DAY. PACKAGING WAS NOT SAVED AT MEDICAL DOCTOR OFFICE. HOSPITAL WAS NOTIFIED 2 DAYS AFTER PATIENTS VISIT TO THE MEDICAL DOCTOR OFFICE. THE CONCERN WITH THIS EVENT WAS THAT THE PACKAGING DOESN'T MAKE IT VERY OBVIOUS THAT THE PRODUCT CONTAINS LATEX. EVEN THOUGH REGISTERED NURSE WAS AWARE OF PATIENTS ALLERGY, THEY WERE NOT AWARE T

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Irritation; Reaction; Skin Irritation; Swelling

  MAUDE report 10480163 ↗
• MalfunctionOct 16, 2019Inaccurate Flow Rate; Obstruction of Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE URINE WOULD NOT DRAIN OUT OF THE CATHETER AFTER PLACEMENT. THE CATHETER WAS REPLACED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9199320 ↗
• InjuryOct 19, 2018Leak/Splash; Fracture; Leak/Splash

  IT WAS REPORTED THAT DURING URINE DRAINAGE, A FRACTURE WAS OBSERVED AT THE TUBING JUNCTION SEAL AND AT THE BASE OF THE COLLECTION BAG. THE PATIENT HAD A URINARY TRACT INFECTION AFTER THIS EVENT. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6)2018 , THE PATIENT RECEIVED TREATMENT FOR THE URINARY TRACT INFECTION. THE TYPE OF MEDICATION IS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 7987041 ↗
• MalfunctionSep 18, 2017Leak/Splash

  IT WAS REPORTED THAT UPON OPENING THE FOLEY TRAY, THE BETADINE FROM THE SWAB STICKS LEAKED INTO THE TRAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6873459 ↗

Other C. R. Bard, Inc. products

• Bardex I.C. Foley Catheter26 models · 3,607 reports
• Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
• Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
• Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
• Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
• Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
• PureWick Female External Catheter5 models · 1,184 reports
• Bardex All-Silicone Foley Catheter12 models · 1,170 reports