SureStep Foley Tray System Bardex IC Complete CareRecalls & reported problems across all models

We found 14 models of SureStep Foley Tray System Bardex IC Complete Care by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 108 adverse event reports in the FDA's MAUDE database, received between Apr 18, 2017 and Oct 15, 2025 — classified as 1 injury, 107 malfunctions.

The most frequently reported specific device problem is “Component Missing” (22 reports).

7 FDA recall records name at least one of these models by its device identifier, 6 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

SureStep Foley Tray System Bardex 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.

1. Jun 25, 2026Open, 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 14 of these models · Recall details · FDA record ↗

2. Aug 5, 2021Open, Classified

   There is potential for packaging defects that may impact the sterile barrier.

   Z-2526-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

3. Aug 5, 2021Open, Classified

   There is potential for packaging defects that may impact the sterile barrier.

   Z-2525-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

4. Aug 5, 2021Open, Classified

   There is potential for packaging defects that may impact the sterile barrier.

   Z-2524-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

5. Aug 5, 2021Open, Classified

   There is potential for packaging defects that may impact the sterile barrier.

   Z-2523-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

6. Aug 5, 2021Open, Classified

   There is potential for packaging defects that may impact the sterile barrier.

   Z-2522-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

7. Apr 15, 2020Terminated

   There is potential for a white paper-type residue attached to the catheter.

   Z-1970-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported SureStep Foley Tray System Bardex IC Complete Care problems

SureStep Foley Tray System Bardex 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 Bardex® IC Complete Care® A303316A

  CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
  2 recalls62 reports
• SureStep™ Foley Tray System Bardex® IC Complete Care® A304716A

  CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
  2 recalls9 reports
• SureStep™ Foley Tray System Bardex® IC Complete Care® A300316A

  CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
  2 recalls7 reports
• SureStep™ Foley Tray System Bardex® IC Complete Care® A303318A

  CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
  2 recalls4 reports
• SureStep™ Foley Tray System Bardex® IC Complete Care® A300314A

  CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
  2 recalls2 reports
• SureStep™ Foley Tray System Bardex® IC Complete Care® A300318A

  CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
  2 recalls1 report
• SureStep™ Foley Tray System Bardex® IC Complete Care® A303314A

  CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
  1 recall12 reports
• SureStep™ Foley Tray System Bardex® IC Complete Care® A304416A

  CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
  1 recall7 reports
• SureStep™ Foley Tray System Bardex® IC Complete Care® A903316A

  CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
  1 recall2 reports
• SureStep™ Foley Tray System Bardex® IC Complete Care® A319416A

  CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
  1 recall1 report
• SureStep™ Foley Tray System Bardex® IC Complete Care® A304718A

  CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
  1 recall1 report
• SureStep™ Foley Tray System Bardex® IC Complete Care® A319418A

  CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
  1 recall0 reports
• SureStep™ Foley Tray System Bardex® IC Complete Care® A304714A

  CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
  1 recall0 reports
• SureStep™ Foley Tray System Bardex® IC Complete Care A903318A

  CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
  1 recall0 reports

Recent SureStep Foley Tray System Bardex 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.

• MalfunctionOct 15, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THERE WAS NO LUBRICATION SYRINGE INSIDE THE FOLEY KIT FOR INSERTION AND HAD 2 STERILE WATER SYRINGES INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289601 ↗
• MalfunctionSep 9, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT THE SURESTEP FOLEY TRAY WAS DAMAGED, LEAKING OBSERVED WITHIN INNER PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006371 ↗
• MalfunctionAug 14, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT CUSTOMER ORDERED 2 CASES OF SAMPLES OF COUDE BARDEX IC FOLEYS. CUSTOMER HAD NOT OPENED EACH TRAY BUT SO FAR 2 OUT OF EACH BOX WERE STANDARD LATEX AND NOT BARDEX IC FOLEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805351 ↗
• MalfunctionAug 12, 2025Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY BALLOON INFLATION SOLUTION WAS LUBRICATING GEL NOT STERILE WATER. BOTH SYRINGES WERE LABELED AS GEL, BUT THE 2ND GEL WAS IN THE POSITION OF THE STERILE WATER, BASICALLY 2 LUBRICATING GEL SYRINGES CAME IN THE KIT AND NO STERILE WATER. NO IMPACT TO PATIENT LUCKILY IT WAS NOTICED BEFORE INFLATING BALLOON THAT THE SYRINGE IN THE SPOT STERILE WATER SPOT WAS ALSO LUBRICATING GEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784088 ↗
• MalfunctionAug 12, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT CUSTOMER ORDERED 2 CASES OF SAMPLES OF COUDE BARDEX IC FOLEYS. CUSTOMER HAD NOT OPENED EACH TRAY BUT SO FAR 2 OUT OF EACH BOX WERE STANDARD LATEX AND NOT BARDEX IC FOLEY. PER FOLLOW UP RECEIVED VIA EMAIL ON 16SEP2025 STATED THAT THEY WERE NEVER IN CONTACT WITH A PATIENT. THEY STILL HAD THE UNOPENED FOLEYS. THEY RECEIVED A RETURN BOX BUT AND NOT SURE IF THEY WOULD ALL FIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783186 ↗
• MalfunctionAug 12, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THEY ORDERED 2 CASES OF SAMPLES - A304416A AND A304716A BOTH SHOULD BE COUDE BARDEX IC FOLEYS. THEY HAD NOT OPENED EACH FOLEY TRAY BUT SO FAR 2 OUT OF EACH BOX WERE THEIR STANDARD LATEX AND NOT BARDEX IC. PER FOLLOW UP RECEIVED VIA EMAIL ON 16SEP2025 STATED THAT THEY WERE NEVER IN CONTACT WITH A PATIENT. THEY STILL HAD THE UNOPENED FOLEYS. THEY RECEIVED A RETURN BOX BUT AM NOT SURE IF THEY WILL ALL FIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782985 ↗
• InjuryJun 23, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT'S FOLEY CATHETER WAS NOTED TO BE OUTSIDE OF THE URETHRA. NO VISIBLE TRAUMA TO THE URINARY MEATUS. INDWELLING FOLEY CATHETER TIP WAS NOT INTACT. THE URINARY MEATUS WAS ASSESSED, NO INDWELLING CATHETER TIP PRESENT. MD AND CHARGE NURSE IMMEDIATELY NOTIFIED. X-RAY NEGATIVE FOR FOREIGN BODY.

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

  MAUDE report 22308650 ↗
• MalfunctionJun 17, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT MATERIAL # A303316A LOT # NGJX6399 OUT DATE 31MAY2027. THERE WAS A PICTURE OF THE FRONT AND THE BACK. ONE TRAY SAID LATEX FREE THE OTHER SAID LATEX, THEY WERE THE SAME FOLEY TRAYS WITH THE SAME PRODUCT NUMBER, LOT NUMBER AND OUTDATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236634 ↗
• MalfunctionJun 3, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THEY WERE REACHING OUT ON BEHALF OF ASPIRUS WAUSAU HOSPITAL. THEY HAD THE END USER REACH OUT WITH THE CONCERN/ QUESTION. PRODUCT #A303316A, LOT #NGJX6399, OUT DATE (B)(6) 2027. THERE WAS A PICTURE OF THE FRONT AND THE BACK. ONE TRAY SAYS LATEX FREE THE OTHER SAYS LATEX, THEY WERE THE SAME TRAYS WITH THE SAME PRODUCT NUMBER, LOT NUMBER AND OUTDATE. THEY NEED TO KNOW HOW ONE CAN BE LATEX AND THE OTHER LATEX FREE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131365 ↗
• MalfunctionJun 3, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT CUSTOMER RECEIVED 1 CASE OF BRDA303316A FOLEY TRAY WITH BRDA303416A PRODUCT INSIDE UNDER LOT#NGJX6399.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131356 ↗
• MalfunctionMay 28, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT IN FOLEY TRAY, 10CC SYRINGE OF STERILE WATER WAS NOT CAPPED AND HAD 1ML OF FLUID IN IT. AS PER INFORMATION RECEIVED VIA MAIL ON 29MAY2025, IT WAS REPORTED THAT THERE WERE NO PHYSICAL SAMPLE AVAILABLE. ALL IDENTIFYING INFORMATION AVAILABLE IN THE REPORT, SERIAL NUMBER NOT AVAILABLE. THERE IS NO DETECTABLE HARM TO PATIENT, MEDICAL INTERVENTION WAS NOT REQUIRED, THE REPORT AS SUBMITTED WAS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097298 ↗
• MalfunctionMay 14, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THERE WAS REFERENCE IN INSERT VERSUS REFERENCE IN LABEL DID NOT MATCH IN FOLEY TRAY. PER FOLLOW UP RESPONSE RECEIVED VIA EMAIL ON 09MAY2025, THE SITUATION WAS THAT IN THE LABEL CASE REFLECT REORDER A303316A, BUT IN THE COMPONENT REFLECT A303416A REFERENCE DID NOT MATCH. NO IMPACT TO THE PATIENT, THIS WAS CONFIRMED DURING INCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017839 ↗
• MalfunctionApr 17, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT FOLEY KIT WAS OPENED, THE 10 CC SYRINGE OF STERILE WATER ONLY HAD 1 CC OF WATER, NO CAP FOUND. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854733 ↗
• MalfunctionApr 16, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT TODAY A LABELLING ISSUE WAS BROUGHT TO THEIR ATTENTION ON 16FR FOLEY CATH TRAYS. THEY ORDER ITEM#: A303316A A 16 FR BARDEX FOLEY CATH TRAY AND THAT WAS WHAT THE OUTSIDE OF THE BOX STATED BUT INSIDE THE LABEL/COVER SHEET OF THE SEALED PACKAGE STATES#: A303416A, INDICATING A LUBRI-SIL CATH. TO MAKE IT MORE CONFUSED, THE BANDED, STERILIZED WRAPPED TRAY ITSELF STATES ITEM#: A303316A. THEY ATTACHED A SCAN OF THE FRONT AND BACK OF THE PACKAGE. THEY CHECKED THE OTHER CASES IN LOT#: NGJX6399 ON THEIR SHELF AND THEY WERE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21849364 ↗
• MalfunctionMar 14, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A FOLEY CATHETER ASSESSMENT, THE SURESTEP FOLEY TRAY ONLY HAD 2 FOAM SWAB STICKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21605305 ↗

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