SureStep Foley Tray System Bard Lubri-Sil Foley CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 10 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one SureStep Foley Tray System Bard Lubri-Sil Foley Catheter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 2
We found 10 models of SureStep Foley Tray System Bard Lubri-Sil Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Apr 18, 2017 and Aug 3, 2026 — classified as 2 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Component Missing” (8 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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 Bard Lubri-Sil 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-3115-2026 · Root cause: Under Investigation by firm · names 3 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-2537-2021 · Root cause: Packaging change control · Recall details · FDA record ↗
Most reported SureStep Foley Tray System Bard Lubri-Sil Foley Catheter problems
Device problems
- Component Missing8
- Device Contamination with Chemical or Other Material5
- Difficult to Remove4
- Component Misassembled3
- Fluid/Blood Leak3
- Material Split, Cut or Torn3
- Break2
- Burst Container or Vessel2
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- No Known Impact Or Consequence To Patient8
- No Patient Involvement2
- Patient Problem/Medical Problem2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Burning Sensation1
- No Code Available1
- No Consequences Or Impact To Patient1
SureStep Foley Tray System Bard Lubri-Sil Foley Catheter models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter A947316CATHETER, RETENTION TYPE, BALLOON1 recall27 reports
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter A947314CATHETER, RETENTION TYPE, BALLOON1 recall3 reports
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter A907316CATHETER, RETENTION TYPE, BALLOON1 recall3 reports
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter A943216CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter A948316CATHETER, RETENTION TYPE, BALLOON4 reports
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter A947318CATHETER, RETENTION TYPE, BALLOON1 report
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter A943214CATHETER, RETENTION TYPE, BALLOON1 report
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter A948314CATHETER, RETENTION TYPE, BALLOON1 report
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter A902214CATHETER, RETENTION TYPE, BALLOON1 report
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter A902216CATHETER, RETENTION TYPE, BALLOON1 report
Recent SureStep Foley Tray System Bard Lubri-Sil Foley Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2026Material Puncture/Hole; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50124268 ↗MalfunctionNov 10, 2025Component Missing; Component Misassembled; Component Missing; Component Misassembled
IT WAS REPORTED THAT THE FOLEY KIT ONLY CONTAINED ONE STERILE BETADINE SWAP INSTEAD OF THREE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23512476 ↗MalfunctionOct 20, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A NURSE OPENED A FOLEY TRAY AND NOTICED THERE WAS A CHALKY RESIDUE ON THE TUBING. ANOTHER FOLEY TRAY WAS OPENED AND THERE WAS ALSO THE SAME CHALKY RESIDUE ON THAT ONE AS WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23343364 ↗MalfunctionSep 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE CUSTOMER RECEIVED A COMPLAINT FROM THE CLINICAL STAFF ABOUT A LATEX FREE FOLEY KIT HAVING A HAIR SHRINK WRAPPED TO THE FOLEY. A SECOND KIT WAS OPENED WITH A DIFFERENT LOT NUMBER AND THAT KIT WAS NOT AFFECTED. THEY WERE NOT SURE BUT HAD A COMPLAINT REGARDING CATALOG # A947316. THEY WERE STILL WAITING ON THEIR CRD TEAM TO DETERMINE IF THEY NEED TO REMOVE THE LOT. THEY JUST WANTED TO GET THAT AND THEN START THE INVESTIGATION PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23073171 ↗MalfunctionSep 10, 2025Component Missing; Component Missing
IT WAS REPORTED THAT THE KIT MISSING COMPONENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23020067 ↗MalfunctionAug 12, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT UPON OPENING A BD SURESTEP FOLEY TRAY (CAT #A947316) IN AN OR SUITE, THE RN DISCOVERED A BD EMPLOYEE'S BADGE FROM NOGALES, MX PLANT INSIDE THE STERILE TRAY. THIS IS A SERIOUS BREACH OF STERILIZATION PROTOCOL AND RAISES CONCERNS ABOUT THE INTEGRITY OF YOUR MANUFACTURING PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22787726 ↗MalfunctionJun 24, 2025Deflation Problem; Defective Component; Infusion or Flow Problem
RN COULDN'T PULL ANYTHING FROM THE BALLOON. RN HAD TO REPOSITION THE PATIENT, TILT THE BED AND SLIGHTLY TUG ON THE FOLEY TO BE ABLE TO GET ANYTHING OUT. EVENTUALLY RN WAS ABLE TO PULL THE WHOLE 10 ML
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22318660 ↗MalfunctionApr 22, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED THAT 10CC STERILE WATER SYRINGE FOR BALLOON INFLATION WAS ONLY 3CC VOLUME AND HAD NOT CAP ON IT. THIS KIT HAD THE YELLOW STICKER STATING NO STERILE GLOVES WHICH WAS RECENTLY REQUESTED TO BE REM FROM THEIR SHELVES AND REPLACED WITH KIT THAT HAD NEC PARTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21881383 ↗MalfunctionApr 21, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED THAT 10CC STERILE WATER SYRINGE FOR BALLOON INFLATION WAS ONLY 3CC VOLUME AND HAD NOT CAP ON IT. PLEASE NOTE THAT KIT HAD THE YELLOW STICKER STATED NO STERILE GLOVES WHICH WAS RECENTLY REQUESTED TO BE REMEMBER FROM THEIR SHELVES AND REPLACED WITH KIT THAT HAD NEC PARTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21873061 ↗MalfunctionMar 26, 2025Component Missing; Component Missing
IT WAS REPORTED THAT DURING FOLEY LIFECYCLE ASSESSMENT, THE FOLEY TRAY THAT THE NURSE PULLED FROM THEIR SUPPLY ROOM DID NOT HAVE IODINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21696649 ↗MalfunctionMar 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT BROKEN OR COMPROMISED TUBING AND LEAKING. TUBING ON FOLEY CATHETER CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21662947 ↗MalfunctionDec 2, 2024Component Missing; Component Missing
IT WAS REPORTED THAT THE STATLOCK WAS MISSING FROM THE FOLEY TRAY. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 06DEC2024, STATED THAT THEY OPENED THE FOLEY CATHETER KIT EXPECTING ALL ITEMS TO BE IN THE KIT AS SHOWN ON THE OUTSIDE WHILE IN THE PATIENT¿S ROOM. ALL OTHER ITEMS WERE IN PLACE, EXCEPT FOR THE STATLOCK SECUREMENT DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20825088 ↗MalfunctionNov 18, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT FOLEY TRAY LEAKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20706647 ↗MalfunctionJul 16, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THEY INSERTED FOLEY CATHETER AND WENT TO DEFLATE BALLOON AND WOULD NOT DEFLATE, PULLED A SECOND ONE SAME ISSUE OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19749851 ↗MalfunctionJun 19, 2024Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT WITHIN THE LAST COUPLE DAYS, THEY HAD FOUR INCIDENTS OF SURESTEP FOLEY TRAYS FAILING IN THE MIDDLE OF PROCEDURES, STATED THAT TWO CATHETERS WOULD NOT DEFLATE. ONE CATHETER WOULD NOT INFLATE. ONE CATHETER BURST INSIDE A PATIENT. PER FOLLOW UP VIA PHONE ON 07JUNE2024, IT WAS REPORTED THAT THIS INCIDENT HAD HAPPENED ABOUT 4-5 ADDITIONAL TIMES. THEY HAD ALREADY FILED A COMPLAINT REGARDING THEM. THERE WAS NO PATIENT INJURY, BUT PATIENT(S) WAS IMPACTED DUE TO THE BALLOON BURSTING INSIDE OF THEM. THEY DID NOT KNOW HOW IT WAS REMOVED BECAUSE THAT WAS CLINICAL AND WAS NOT CLINICAL. THEY COULD NOT PROVIDE ANY MORE INFORMATION REGARDING THE INCIDENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19567078 ↗
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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