SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter Tray A942216Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00801741074110), received between Apr 6, 2018 and Mar 17, 2026 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Wrong Label” (13 reports).

2 FDA recall records name this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

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-3115-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Aug 5, 2021Class IIOpen, Classified

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

   Z-2541-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT IN THE OPERATING ROOM, THE REGISTERED NURSE WAS SETTING UP A 2ND INDWELLING CATHETER KIT BECAUSE THE FIRST KIT HAD A HAIR IN IT. THE REGISTERED NURSE NOTICED A HAIR INSIDE THE SYRINGE ON THE PLUNGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24622357 ↗
• MalfunctionMar 17, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE CUSTOMER THAT IN THE OPERATING ROOM THE CUSTOMER HAD BEEN SETTING UP TO INSERT THE INDWELLING CATHETER AND NOTICED A HAIR ON THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621869 ↗
• MalfunctionJan 30, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A CAREGIVER FOUND A HAIR IN FOLEY TRAY KIT. THAT WAS OCCURRED EITHER IN THEIR A942216 OR A942218 TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24226377 ↗
• MalfunctionNov 4, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOLEY TRAY HAS A FOREIGN OBJECT FOUND IN A TRAY. THIS IS THE SECOND TRAY THEY HAVE FOUND WITH A FOREIGN OBJECT IN IT. PER FOLLOW UP INFORMATION RECEIVED FROM CUSTOMER VIA EMAIL ON 28OCT2025. IT WAS REPORTED THAT SAMPLE WAS ALREADY RETURNED, WHICH WAS COORDINATED WITH LOCAL BD REPRESENTATIVE. DEFECT WAS NOTICED BEFORE USE. NO HARM WAS NOTED. FOREIGN OBJECT NOTICED BEFORE THE FOLEY WAS INSERTED. BOTH FOLEY TRAYS THAT CONTAINED FOREIGN MATERIAL ALONG WITH THE PICTURES SUBMITTED BY THE REPORTING CLINICIAN. (LOT #NGKN4346) AND (LOT # NGKR2118).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23471898 ↗
• MalfunctionOct 15, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER CALLED TO REPORT THAT THE FOLEY TRAY THEY HAVE BEEN RECEIVING HAS NOT BEING COMING WITH A FLUSH. NO PATIENT HARM WAS REPORTED, AND THE CUSTOMER WOULD LIKE TO SPEAK TO SOMEONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301932 ↗
• MalfunctionSep 23, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  CUSTOMER REACHED OUT SAYING THEY FOUND A HAIR IN THEIR FOLEY TRAY. THE CUSTOMER IS ASKING FOR A REPLACEMENT CASE. PER FOLLOW UP INFORMATION RECEIVED ON 25NOV2025, HAIR WAS FOUND INSIDE THE TRAY UPON OPENING THE PACKAGE. NO PATIENT IMPACT WAS REPORTED. NO SAMPLE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23123098 ↗
• MalfunctionJul 29, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE FOLEY TRAY HAS A FOREIGN OBJECT FOUND IN A TRAY. THIS IS THE SECOND TRAY THEY HAVE FOUND WITH A FOREIGN OBJECT IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644520 ↗
• MalfunctionJun 27, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT BEFORE USE, THE NURSING STAFF REPORTED THAT UPON OPENING THE TRAY, THE IODINE PACKET WAS FOUND TO BE RUPTURED, AND THE SOLUTION HAD LEAKED THROUGHOUT THE ENTIRE TRAY. THIS INCIDENT HAS AFFECTED THE USABILITY OF THE KIT. THEY FOUND 5 TRAYS WITH SAME ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346389 ↗
• MalfunctionJun 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT REGISTERED NURSE OPENED A FOLEY CATHETER KIT AND DURING PREPARATION THEY FOUND THE WATER SYRINGE WAS CRACKED AND LEAKING WITHIN THE KIT. THE KIT WAS STILL UTILIZED; HOWEVER, THE TEAM HAD TO ACQUIRE A NEW SYRINGE AND WATER DURING THE STERILE PREPARATION/ PROCEDURE. THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) MENTIONED THAT ANOTHER EMPLOYEE WAS RECENTLY HAD SIMILAR ISSUES WITH A SYRINGE, SO THEY WERE REPORTING THIS TO TRACK IF THERE WERE FUTURE OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285805 ↗
• MalfunctionJun 3, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE MEDLINE RECEIVED 4 CASES OF BRDA942216 FOLEY TRAY BUT INSIDE THE CASE FROM THIS LOT WAS BRDA303316A. ALSO RECEIVED SEVERAL FOLEY TRAY DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131364 ↗
• MalfunctionMay 7, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THERE WAS A LATEX FREE KIT, BUT THE GLOVES INSIDE THE PACK WERE LATEX GLOVES. IT WAS NOTED THAT GIVEN LOT# NGJX4320. PER UCC MAIL NOTIFICATION RECEIVED ON 06MAY2025, BASED ON THE PHOTOS IN THE COMPLAINT, THE WRONG INSERT SHEET WAS PROVIDED FOR LOT NGJX4320. PHOTO ONE SHOWN THE LOT NUMBER ON THE BELLY BAND NGJX4320 FOR A942216 WHICH WAS A LATEX-FREE CODE. PHOTO TWO SHOWN THE FRONT WITH THE INSERT SHEET FOR THAT LOT AND IT SAYS THE ITEM CONTAINS LATEX; THIS SAME PHOTO ALSO SHOWS A PARTIAL REF THAT DID NOT CORRESPOND TO A942216. THIS WAS PART OF THE ONGOING COMPLAINTS FOR THIS LOT# WHERE THE INSERT SHEET PROVIDED WAS FOR A303316A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977512 ↗
• MalfunctionApr 2, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT CUSTOMER WAS RECEIVED A MISLABELED PRODUCT ON LINE 23 FOR (B)(4) EA AND ORDERED (B)(6) FOLEY TRAY AND INSIDE THE BOX (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751537 ↗
• MalfunctionMar 12, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT CUSTOMER EMAILED REGARDING MIS-LABELING ISSUE FOR AN ITEM, WHEN OPENED ONE OF THESE AND IT HAD THE CORRECT PRODUCT INSIDE, SO THESE WERE MISS-LABELED WITH (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583149 ↗
• MalfunctionMar 11, 2025Wrong Label; Wrong Label

  IT WAS REPORTED CUSTOMER HAD A SERIOUS ISSUE WITH THIS TRAY #A942216. THIS TRAY WITH REF# A942216 SHOULD BE A NON LATEX FOLEY. HOWEVER, LOT NGJX4320 HAS BEEN LABELED INCORRECTLY WITH A LATEX FOLEY TRAY. PLEASE SEE THE IMAGES BELOW FOR A BETTER REFERENCE. THAT WAS WHAT THE OUTSIDE OF THE CASE LOOKS LIKE AND IT SHOULD HAD TRAYS WITH REF # A942216. HOWEVER, ONCE YOU OPEN THE CASE, THEY HAVE TRAYS WITH REF# A303316A WHICH WERE LATEX, T FLIP THE TRAY OVER TO THE OTHER AND THEY HAVE A STICKER WITH REFERENCE #A942216. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 02APR2025, IT WAS REPORTED THAT THEY HAD MULTIPLE TRAYS AND CASES THAT WERE AFFECTED BY THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21572051 ↗
• MalfunctionMar 11, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE LOT#: NGJX4320, ITEM: A942216 18CA OM, PO: (B)(4). THE CASE WAS LABELED AS A942216 BUT INSIDE THE CASE WAS PACKAGED WITH A303316A. THEY HAD 18CA DEFECTIVE FOLEY TRAY PRODUCT. A942216 WAS LATEX FREE WHILE A303316A IS NOT LATEX FREE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21572050 ↗
• MalfunctionMar 11, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT CUSTOMER HAD A SERIOUS ISSUE WITH THIS TRAY#: A942216. THIS TRAY#: A942216 SHOULD BE A NON-LATEX FOLEY. HOWEVER, LOT#: NGJX4320 HAD BEEN LABELED INCORRECTLY WITH A LATEX TRAY. OUTSIDE OF THE CASE LOOKED LIKE AND IT SHOULD HAVE TRAYS#: A942216. HOWEVER, ONCE OPENED THE CASE, THEY HAD TRAYS WITH REF#: A303316A WHICH WERE LATEX, FLIP THE TRAY OVER TO THE OTHER AND THEY HAD A STICKER WITH REFERENCE #: A942216.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21572049 ↗
• MalfunctionMar 10, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT ON BOX FOLEY TRAY WAS A942216 BUT ITEM INSIDE BOX WAS A303316A. CUSTOMER WOULD REORDER FROM CARDINAL BUT WANTED TO MAKE YOU AWARE OF INCORRECT PACKAGING AND LABELS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558997 ↗
• MalfunctionMar 7, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT CUSTOMER HAD 8 FOLEY TRAYS WERE LABELED A942216 MISLABELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546475 ↗
• MalfunctionMar 6, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE FOLEY TRAY BOXES RECEIVED WERE LABELED A942216 NO LATEX, HOWEVER, ITEMS IN THE BOXES ARE LABELED A303316A LATEX. BAND PACKAGING ON BACK OF PRODUCT STATES A942216 WITH CORRECT LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21535397 ↗
• MalfunctionMar 4, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT CUSTOMER IDENTIFIED 41 FOLEY TRAYS AS MISLABELED. THIS TRAY WITH REF#A942216 FOLEY TRAY SHOULD BE A NON-LATEX FOLEY. HOWEVER, LOT #NGJX4320 HAD BEEN LABELED INCORRECTLY WITH A LATEX TRAY. ALL AROUND, THIS TRAY WAS MISLABELED. THEY HAD PULLED ALL OF THEIR PRODUCTS FROM THE SHELF, AND THEY WERE CURRENTLY PULLING THEM FROM THE FLOORS. THEY HAVE PLACED AN ORDER OF LOT# 370941 A319516AM TO START REPLACING THIS TRAY. CUSTOMER SUBMITTED A 2ND COMPLAINT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 14FEB2025, IT WAS REPORTED THAT ON 12FEBRUARY2025 THEY HAD SUBMITTED THE SAME COMPLAINT BUT ON 14FEBRUARY2025 THIS HOSPITAL FOUND 4 MORE FOLEY TRAYS THAT WERE MISLABELED. THIS WAS THE SAME LOT NUMBER FROM THE 1ST COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21515659 ↗
• MalfunctionFeb 28, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT CUSTOMER IDENTIFIED 41 FOLEY TRAYS AS MISLABELED. THIS TRAY WITH REF#A942216 FOLEY TRAY SHOULD BE A NON-LATEX FOLEY. HOWEVER, LOT #NGJX4320 HAD BEEN LABELED INCORRECTLY WITH A LATEX TRAY. ALL AROUND, THIS TRAY WAS MISLABELED. THEY HAD PULLED ALL OF THEIR PRODUCTS FROM THE SHELF, AND THEY WERE CURRENTLY PULLING THEM FROM THE FLOORS. THEY HAVE PLACED AN ORDER OF LOT# 370941, A319516AM TO START REPLACING THIS TRAY. CUSTOMER SUBMITTED A 2ND COMPLAINT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 14FEB2025, IT WAS REPORTED THAT ON 12FEBRUARY2025 THEY HAD SUBMITTED THE SAME COMPLAINT BUT ON 14FEBRUARY2025 THIS HOSPITAL FOUND 4 MORE FOLEY TRAYS THAT WERE MISLABELED. THIS WAS THE SAME LOT NUMBER FROM THE 1ST COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21493816 ↗
• MalfunctionFeb 26, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT ONE CASE OF FOLEY TRAY WAS LABELED WITH THE INCORRECT REFERENCE SUPPOSED TO BE PCN #(B)(6) BUT HAD PCN #(B)(6). THEY PULLED PRODUCT OUT AND IT DID APPEAR TO BE WHAT THEY INTENDED TO ORDER. PER ADDITIONAL INFORMATION RECEIVED ON 15FEB2025, IT WAS REPORTED THAT THE SHEET INSIDE THE PACKAGE HAD A DIFFERENT ITEM NUMBER. WHEN OPENING THE CASE, THE INCORRECT ITEM (B)(6) WAS IN THE BOX THE ITEMS HAVE 2 DIFFERENT MANUFACTURING NUMBERS ON THEM, SO NOT ABLE TO USE BECAUSE OF THIS. LUCKILY, NONE OF THE INCORRECT TRAYS WERE USED QUANTITY 10 PER CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469053 ↗
• MalfunctionJan 22, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON WOULD NOT INFLATE OR DEFLATE APPROPRIATELY. UPON INSERTION OF FOLEY URINE WAS RETURNED, BALLOON WAS THEN ATTEMPTED TO BE INFLATED, BALLOON ONLY ACCEPTED 4 CC OF FLUID BEFORE IT WOULD NOT INFLATE ANY FURTHER. ATTEMPT THEN MADE TO RETRACT FLUID FROM BALLOON AND IT WOULD NOT COME BACK OUT. WE WERE ABLE TO MANIPULATE THE BALLOON REPEATEDLY UNTIL MOST THE FLUID WAS REMOVED FROM THE BALLOON SO WE COULD THEN REMOVE THE CATHETER. CATHETER PLACED IN RED BIOHAZARD BAG AND GIVEN TO CLINICAL MANAGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208988 ↗
• MalfunctionJan 21, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT TWO RECENT EVENTS OCCURRED WITH BARD CATHETERS AT FACILITY. FIRST ONE STATED THAT UNSTERILE PACKAGING. A LONG BLACK HAIR WAS FOUND WRAPPED AROUND STERILE DRESSING IN THE PACKAGE. TRAY DISCARDED AND NEW FOLEY TRAY OPENED. DID NOT REACH PATIENT. SECOND ONE STATED THAT FOLEY BALLOON NOT DEFLATED COMPLETELY DURING REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196857 ↗
• MalfunctionJan 21, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWO RECENT EVENTS OCCURRED WITH BARD CATHETERS AT FACILITY. FIRST ONE STATED THAT UNSTERILE PACKAGING. A LONG BLACK HAIR WAS FOUND WRAPPED AROUND STERILE DRESSING IN THE PACKAGE. TRAY DISCARDED AND NEW FOLEY TRAY OPENED. DID NOT REACH PATIENT. SECOND ONE STATED THAT FOLEY BALLOON NOT DEFLATED COMPLETELY DURING REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196855 ↗