SureStep Foley Tray System Lubri-Sil IC Complete CareRecalls & reported problems across all models
C. R. Bard, Inc. · 14 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
5 open recalls name at least one SureStep Foley Tray System Lubri-Sil IC Complete Care model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 105
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 5
We found 14 models of SureStep Foley Tray System Lubri-Sil IC Complete Care by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 105 adverse event reports in the FDA's MAUDE database, received between May 19, 2017 and Sep 15, 2026 — classified as 1 injury, 104 malfunctions.
The most frequently reported specific device problem is “Component Missing” (21 reports).
5 FDA recall records name at least one of these models by its device identifier, 5 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 Lubri-Sil IC Complete Care 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-3116-2026 · Root cause: Under Investigation by firm · names 2 of these models · 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-3115-2026 · Root cause: Under Investigation by firm · names 9 of these models · Recall details · FDA record ↗
- Jun 18, 2025Class IIOpen, Classified
Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.
Z-2462-2025 · Root cause: Process design · Recall details · FDA record ↗
- Aug 5, 2021Class IIOpen, Classified
There is potential for packaging defects that may impact the sterile barrier.
Z-2540-2021 · 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-2538-2021 · Root cause: Packaging change control · Recall details · FDA record ↗
Most reported SureStep Foley Tray System Lubri-Sil IC Complete Care problems
Device problems
- Component Missing21
- Component Misassembled12
- Fluid/Blood Leak7
- Leak/Splash5
- Material Puncture/Hole5
- Short Fill5
- Deformation Due to Compressive Stress4
- Device Contaminated During Manufacture or Shipping4
Patient problems
- No Clinical Signs, Symptoms or Conditions68
- No Known Impact Or Consequence To Patient21
- No Consequences Or Impact To Patient12
- Insufficient Information4
- Discomfort3
- No Information3
- No Patient Involvement3
- Pain3
SureStep Foley Tray System Lubri-Sil IC Complete Care models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A303416ACATHETER, RETENTION TYPE, BALLOON2 recalls45 reports
- SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A319516AMCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES2 recalls23 reports
- SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A300416ACATHETER, RETENTION TYPE, BALLOON1 recall9 reports
- SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A319514AMCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 recall7 reports
- SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A303414ACATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 recall6 reports
- SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A307416ACATHETER, RETENTION TYPE, BALLOON1 recall4 reports
- SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A303418ACATHETER, RETENTION TYPE, BALLOON1 recall3 reports
- SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A319516ACATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 recall3 reports
- SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A300418ACATHETER, RETENTION TYPE, BALLOON1 recall1 report
- SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A307418ACATHETER, RETENTION TYPE, BALLOON1 recall1 report
- SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A300414ACATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 recall0 reports
- SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A319514ACATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 recall0 reports
- SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A307414ACATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES2 reports
- SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A900414ACATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 report
Recent SureStep Foley Tray System Lubri-Sil IC Complete Care adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Material Puncture/Hole; Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781538 ↗MalfunctionJun 25, 2026Difficult to Remove
IT WAS REPORTED THAT THE FOLEY CATHETER HAD BALLOON THAT COULD NOT BE DEFLATED, AND PHYSICIANS HAD TO REMOVE CATHETER WHILE BALLOON WAS STILL INFLATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25622649 ↗MalfunctionFeb 19, 2026Erratic or Intermittent Display
IT WAS REPORTED BY CUSTOMER THAT THE TRAYS ARE NOT PROVIDING ACCURATE TEMPERATURE READINGS AND HAVE ARRIVED MISSING COMPONENTS, INCLUDING SYRINGES AND STERILE WATER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388326 ↗MalfunctionJan 30, 2026Material Fragmentation
IT WAS REPORTED THAT AS PER THE CUSTOMER THEY JUST WANTED TO REPORT THE ISSUE TO THEIR COMPANY TO SEE IF THAT HAD BEEN AN ONGOING ISSUE FOR CLIENTS OF THAT DEVICE. THE REPORT TO THEM WAS THAT THE NURSE INSERTED THE FOLEY CATHETER, WAS INFLATING THE BALLOON THAT HOLDS THE WATER. WHILE DISCONNECTING THE SYRINGE THE LUER TIP BROKE OFF INSIDE THE BALLOON PORT AND WAS JAGGED. THAT MADE THE NURSE HAD TO REMOVE THE DEVICE DUE TO POSSIBLE PATIENT INJURY AND INFECTION ROUTE. THE PATIENT HAD ANOTHER SYSTEM PLACED WITHOUT DEVICE ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223871 ↗MalfunctionJan 23, 2026Component Misassembled
IT WAS REPORTED THAT THE TRAY CONTAINING THE CATHETER FOLEY ¿ COMPLETE CARE WITH TEMPERATURE SENSOR, SILICONE 16FR, AND A 350 ML URINE METER WAS USED ON THE PATIENT. THE TRAY STATED THAT IT HAD STERILE WATER IN THE SYRINGE; HOWEVER, THE SYRINGE WAS PRESENT WITHOUT A CAP AND DID NOT CONTAIN ANY STERILE WATER AND IT WAS EMPTY. ANOTHER STAFF MEMBER HAD TO GO AND GET STERILE WATER, WHICH DELAYED THE PROCEDURE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24171733 ↗MalfunctionNov 7, 2025Component Missing; Component Missing
IT WAS REPORTED THAT THE KIT WAS MISSING THE ACTUAL 14FR FOLEY CATHETER. EVERY OTHER ITEM WAS IN THE FOLEY TRAY KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23494940 ↗MalfunctionNov 4, 2025Fungus in Device Environment; Fungus in Device Environment
IT WAS REPORTED THAT THEY FOUND SOME WIPES INSIDE A SURESTEP FOLEY KIT THAT APPEARED TO HAVE MOLD OR SOME SUBSTANCE ON THEM. THE WIPES WERE SAVED AND PRODUCT INFO INCLUDING LOT NUMBER IS BELOW. THE EVENT OCCURRED ON (B)(6) IN L&D. CUSTOMER IS THE POINT OF CONTACT FOR A RETURN BOX AND LABEL. MOLD FOUND ON ONE OF THE 3 SUPPLIED PERI WIPES. CUSTOMER RESPONDED VIA EMAIL ON (B)(6) 2025. IT WAS REPORTED THAT THE SAMPLE WAS SAVED AND IT IS IN UNIT MANAGER OFFICE. PENDING SAMPLE RETURN. LOT: (B)(4) WAS CONFIRMED AS THE AFFECTED LOT. THERE WAS NO HARM TO THE PATIENT. THE ISSUE WAS IDENTIFIED BEFORE USE ON THE PATIENT. IT WAS THE SECOND WIPE IN A PACK OF THREE, AND IT WAS THE WIPE DIRECTLY IN THE MIDDLE. NEITHER OF THE OTHER WIPES HAD ANY SIGNS OF MOLD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23468651 ↗MalfunctionSep 17, 2025Gel Leak; Gel Leak
IT WAS REPORTED THAT FOLEY TRAY WAS DAMAGED, INTERNAL LEAK. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 16SEP2025, IT WAS REPORTED THAT CATH TRAY - (B)(6) - TRAY CATH 16 FR KIT INDWELL LAT FREE 5 CC BALL ¿ WAS DELIVERED BY OUR VENDOR. INVENTORY CONTROL STAFF DISCOVERED THE TRAY WAS DAMAGED (SEE ATTACHED PHOTO). THERE WERE NO OBVIOUS SIGNS OF DAMAGE TO THE EXTERIOR OF THE PACKAGING, AND THE OUTER POLY WRAP WAS STILL INTACT. THE TRAY WAS REMOVED FROM THE VENDOR¿S DELIVERY TOTE AND ISOLATED AGAINST ACCIDENTAL USE. LEADERSHIP WAS NOTIFIED TO INVESTIGATE, AND A REPORT WAS SUBMITTED TO THE VENDOR. NO OTHER ACTIONS WERE TAKEN TO DETERMINE THE CAUSE OF THE LEAKAGE TO THE TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23073008 ↗MalfunctionAug 28, 2025Defective Device; Defective Device
IT WAS REPORTED THE END USER HAS STATED THERE WAS A MALFUNCTION WITH THIS ITEM AND WE HAVE QUARANTINED THE PRODUCT FOR YOUR EVALUATION. PRODUCT A300416A, LOT #NGKR2055. TRAY FOLEY IC BAG 16 FR SILICN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22911800 ↗MalfunctionJul 29, 2025Component Missing; Component Missing
IT WAS REPORTED THAT IN FOLEY TRAY, THE SYRINGE WITH LUBE AND SYRINGE WITH STERILE WATER WAS MISSING. CUSTOMER EMAIL RESPONSE RECEIVED ON 25SEP2025. IT WAS REPORTED THAT THE PRODUCT WAS NOT RETAINED AND THE LOT NGKR2059 WAS CONFIRMED AS THE AFFECTED LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22645413 ↗MalfunctionJul 15, 2025Material Puncture/Hole; Device Dislodged or Dislocated; Unintended Deflation
THE FOLEY CATHETER WAS REPLACED VIA RN AT 1100. UPON TURNING PATIENT, AT APPROXIMATELY 1150 AM, THE CATHETER TUBE WAS PULLING OUT OF PATIENT AND THE BALLOON WAS DEFLATED. TWO NURSES EXAMINED THE CATHETER BALLOON FURTHER AND FOUND A HOLE IN THE DEVICE BALLOON. PATIENT WAS ASSESSED AND IT WAS UNKNOWN IF ANY INJURY WAS CAUSED TO THE PATIENT, IF SO, WAS MINOR.
Patient problems: Insufficient Information
MAUDE report 22506301 ↗MalfunctionJul 10, 2025Component Missing; Component Missing
IT WAS REPORTED THAT DURING INSERTION ASSESSMENT TRAY WAS USED AND FOUND TO NOT HAVE SWABS IN THE TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22468735 ↗MalfunctionJun 16, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED THAT KIT CONTAINED TWO LUBRICANT SYRINGES INSTEAD OF A STERILE WATER SYRINGE AND A LUBRICANT SYRINGE. NURSE OPENED ANOTHER TRAY TO SEE IF THERE WAS ANOTHER AFFECTED ONE HOWEVER KIT WAS GOOD TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22212222 ↗MalfunctionJun 4, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THERE WAS A KINK IN THE TUBING OF THE FOLEY TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22140762 ↗MalfunctionApr 30, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS NOT HOLDING THE INSTILLATION OF THE STERILE WATER. THE FOLEYS INADVERTENTLY CAME OUT OF THE PATIENT. THE SECOND TIME AROUND, THE CNL TESTED THE BALLOON AND NOTED IT LEAKING. THIS HAPPENED TWICE FOR THIS PATIENT - REQUIRING THE PATIENT TO RECEIVE A TOTAL OF 3 FOLEYS. THEY HAD THE DEFECTIVE PRODUCT AND TO SEND BACK. IT WAS NOTED THAT THE GIVEN LOT# WAS NGHY3201.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21935214 ↗
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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