SureStep Foley Tray System Bardex Lubricath Foley CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
4 open recalls name at least one SureStep Foley Tray System Bardex Lubricath Foley Catheter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 86
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 4
We found 8 models of SureStep Foley Tray System Bardex Lubricath Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 86 adverse event reports in the FDA's MAUDE database, received between May 11, 2017 and Sep 30, 2026 — classified as 5 injuries, 81 malfunctions.
The most frequently reported specific device problem is “Component Missing” (11 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 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
Reports received per month, all models
SureStep Foley Tray System Bardex Lubricath Foley Catheter 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.
- 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-3119-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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 6 of these models · Recall details · FDA record ↗
- Aug 5, 2021Class IIOpen, Classified
There is potential for packaging defects that may impact the sterile barrier.
Z-2536-2021 · Root cause: Packaging change control · Recall details · FDA record ↗
- Aug 5, 2021Class IIOpen, Classified
There is potential for packaging defects that may impact the sterile barrier.
Z-2534-2021 · Root cause: Packaging change control · Recall details · FDA record ↗
Most reported SureStep Foley Tray System Bardex Lubricath Foley Catheter problems
Device problems
- Component Missing11
- Component Misassembled10
- Device Contamination with Chemical or Other Material6
- Gel Leak6
- Short Fill6
- Device Operates Differently Than Expected5
- Fluid/Blood Leak5
- Deformation Due to Compressive Stress4
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- No Known Impact Or Consequence To Patient25
- No Patient Involvement12
- No Consequences Or Impact To Patient11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Urinary Retention3
- Abrasion2
- Foreign Body In Patient2
SureStep Foley Tray System Bardex Lubricath Foley Catheter models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 3 recalls19 reports
- 2 recalls50 reports
- 1 recall6 reports
- 1 recall3 reports
- 1 recall2 reports
- 1 recall0 reports
- 5 reports
- 1 report
Recent SureStep Foley Tray System Bardex Lubricath Foley Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Deformation Due to Compressive Stress
It was reported that we had challenges with or Foley catheters folding over / kinking when the urine enters the bag. Please see the attached photo.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950938 ↗MalfunctionSep 28, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916267 ↗MalfunctionSep 21, 2026Failure to Deflate
Attempted to deflate 16Fr foley catheter for removal but unable to. Added 2cc sterile saline and attempted to deflate again. Only able to remove 4cc. Added 2cc more, then able to deflate fully.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838816 ↗MalfunctionMar 4, 2026
RN WAS ATTEMPTING TO CARE FOR INTUBATED PATIENT, AND WHEN SHE PULLED THE PATIENTS BLANKET BACK, SHE NOTICED A LARGE PUDDLE OF URINE UNDER THE PATIENT. THERE WAS NO OBVIOUS HOLE OR VISUAL FAILURE WITH THE FOLEY, AND IT SEEMED TO JUST NOT BE CONNECTING PROPERLY, LEADING TO THE PUDDLE. THIS RN WAS NOT SURE HOW LONG THE FOLEY HAD BEEN A PROBLEM WITH THIS SPECIFIC PATIENT, BUT THIS AT LEAST THE FIFTH TIME IN THE LAST TWO WEEKS OUR ICU HAS HAD A PROBLEM WITH THIS SPECIFIC TYPE OF FOLEY CATHETER. THIS FAILURE COULD LEAD TO POTENTIAL SKIN BREAKDOWN FOR AN INTUBATED PATIENT, WHICH COULD LEAD TO INFECTION CONTROL ISSUES. ALL FIVE OF THE FAILURES WERE WITH FIVE DIFFERENT PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24505543 ↗MalfunctionJan 23, 2026Material Fragmentation
IT WAS REPORTED THAT WHEN NURSE WAS INSERTING A FOLEY CATHETER IN DOCTORS¿ PATIENT, THE SALINE SYRINGE TIP BROKE OFF INSIDE THE PORT WHEN HE HOOKED IT UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24173009 ↗MalfunctionNov 7, 2025Component Missing; Component Missing
IT WAS REPORTED THAT THE CATHETER KIT WAS SUPPOSED TO HAVE 3 SWAB STICKS BUT ONLY CONTAINED 2 IN THE FOLEY TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23497574 ↗MalfunctionOct 17, 2025Melted; Melted
IT WAS REPORTED TO SUPPLY DISTRIBUTION THAT PRODUCT A902916, LOT NGKS0308 WAS OPENED AND FOUND TO HAVE A FOLEY CATHETER BAG THAT WAS MELTED TO THE OPENING WHERE THEY WOULD LET URINE OUT, IF THEY WERE EMPTYING A CATHETER. THE NURSE WAS UNABLE TO EMPTY THE FOLEY BECAUSE OF THE OPENING SEALED SHUT AND THEY INDICATED THEY HAD TO GET A NEW BAG. THE NURSE MENTIONED THAT WAS THE SECOND TIME THEY NOTICED THAT EXACT SAME DEFECT, BUT THEY DID NOT COLLECT THE LOT NUMBER THE FIRST TIME AROUND, NOR DID THEY SAVE THE DEFECTIVE PRODUCT. THEY HAD RECEIVED OTHER ISSUES WITH THAT PRODUCT AND LOT YET AND DID NOT HAVE THE DEVICE TO SEND BACK FOR QA BUT DID WANT TO FOLLOW UP TO SEE IF THERE WAS A NEED TO PULL THAT LOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23323739 ↗MalfunctionAug 14, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE CUSTOMER STATED THAT THEY RECEIVED A COMPLAINT FROM CAPITOL HILL OR REGARDING A BARD FOLEY CATH TRAY, #A899916. THE DESCRIPTION OF THE PROBLEM WAS MENTIONED BELOW. THERE WAS NOTHING SAVED FROM THE KIT SINCE THEY WERE ABLE TO ADD THE MISSING ITEM TO CONTINUE USING IT. WHILE PREPARING TO PLACE A FOLEY CATHETER IN A PATIENT FOR A SURGICAL PROCEDURE, THEY WERE OPENING AND PREPPING THE TRAY KIT. THERE WAS NO LUBRICATING JELLY IN THE KIT. THERE WERE 2 STERILE WATER SYRINGES. ANESTHESIA WAS ABLE TO PROVIDE STERILE JELLY TO THEIR FIELD, SO NO HARM OR DELAY WAS NOTED IN PATIENT CARE. THE KIT REF# A899916, LOT# NGKS0068 WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22804280 ↗MalfunctionAug 5, 2025Fracture; Fracture
THE INCLUDED STERILE WATER SYRINGE USED TO INFLATE CATHETER BALLOON SPLIT ALONG THE BARREL WHILE ATTEMPTING TO INFLATE THE BALLOON AFTER COUDE CATHETER INSERTION. STERILE WATER THEN LEAKED OUT THE BARREL OF THE SYRINGE. NO RESISTANCE WAS ENCOUNTERED PRIOR TO SPLIT. USED A NEW STERILE SALINE SYRINGE TO FILL THE BALLOON AFTER WITHDRAWING PREVIOUSLY INSTILLED STERILE WATER WITH DIFFERENT EMPTY SYRINGE. PATIENT WAS NOT AFFECTED. CAN SUBMIT IMAGES OF LABELS IF NEEDED, CURRENTLY HOLDING ONTO SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22713673 ↗MalfunctionJul 7, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED WHILE DOING THEIR FOLEY LIFECYCLE ASSESSMENT, NOTICED THAT FOLEY TRAY CONFIGURATION SEEMS OFF. THE UNDERPAD WAS NOT FOLDED THE WAY IT USUALLY WAS. ALSO, THE STERILE WATER AND LUBRICANT JELLY SYRINGES ARE IN WRONG SPOT. THE WATER SYRINGE ON THE RIGHT AND LUBRICANT ON THE LEFT, AND THEREFORE WHEN THEY ATTACH THE WATER SYRINGE IT DID NOT EXPOSE #4 STEP THAT WAS ETCHED ON THE TRAY, WHICH WOULD INSTRUCT DISPENSE LUBE. ALSO, ONE TRAY HAD TWO GLOVES IN, ANOTHER TRAY HAD TWO FENESTRATED DRAPES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22412700 ↗MalfunctionMay 5, 2025Wrong Label; Wrong Label
IT WAS REPORTED THAT THE OUTSIDE OF CASE LISTS A902916 AS PART#, PRODUCT INSIDE CASE IS LABELLED A303316A.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21960952 ↗MalfunctionApr 22, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THIS WAS THE 2ND CATHETER TRAY THAT HAD A YELLOW STICKER THAT STATED THERE WERE NO STERILE GLOVED AND THE STERILE WATER SYRINGE WAS NOT CAPPED AND ONLY HAS 4ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21883272 ↗MalfunctionNov 26, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT ONE OF THE FOLEY TRAYS CONTAINED A PREFILLED SYRINGE THAT WAS EMPTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20787464 ↗MalfunctionNov 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT WHEN OPENED THE FOLEY KIT, IT WAS DISCOVERED THAT THE STERILE WATER SYRINGE USED TO INFLATE THE BALLOON WAS UNCAPPED AND ONLY HAD 1ML OF FLUID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20734630 ↗MalfunctionNov 18, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT CUSTOMER HAD A DEFECTIVE FOLEY KIT. THE SYRINGE WITH THE STERILE WATER FOR THE BALLOON WAS EMPTY AND HAD NO CAP ON IT. NOT ABLE TO USE PRODUCT. STERILITY CONCERNS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20705331 ↗
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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