Lubri-Sil I.C. Complete Care All-Silicone Foley Catheter TrayRecalls & reported problems across all models
C. R. Bard, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Lubri-Sil I.C. Complete Care All-Silicone Foley Catheter Tray model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of Lubri-Sil I.C. Complete Care All-Silicone Foley Catheter Tray by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2019 and Sep 29, 2026 — classified as 38 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (17 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
Lubri-Sil I.C. Complete Care All-Silicone Foley Catheter Tray 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 · Recall details · FDA record ↗
Most reported Lubri-Sil I.C. Complete Care All-Silicone Foley Catheter Tray problems
Device problems
- Deflation Problem17
- Component Missing5
- Difficult to Remove3
- Component Misassembled2
- Gel Leak2
- Inflation Problem2
- Material Fragmentation2
- Short Fill2
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Lubri-Sil I.C. Complete Care All-Silicone Foley Catheter Tray models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Lubri-Sil® I.C. Complete Care® All-Silicone Foley Catheter Tray 300416ACATHETER, RETENTION TYPE, BALLOON1 recall1 report
- Lubri-Sil® I.C. Complete Care® All-Silicone Foley Catheter Tray 900114ACATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES37 reports
Recent Lubri-Sil I.C. Complete Care All-Silicone Foley Catheter Tray adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Restricted Flow rate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940516 ↗MalfunctionDec 4, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS A DIRT ON THE PAPER WRAPPING THE GLOVES IN THE FOLEY TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723074 ↗MalfunctionSep 30, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE SYRINGE WATER INJECTION WAS STIFF, AND THE FOLEY CATHETER BULGES UNEVENLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23179864 ↗MalfunctionSep 8, 2025Component Missing; Component Missing
IT WAS REPORTED THAT WHEN THE FOLEY TRAY WAS OPENED, THERE WAS NO SYRINGE INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22991775 ↗MalfunctionAug 15, 2025Component Missing; Component Missing
IT WAS REPORTED THAT BEFORE USE, THERE WAS NO CATHETER JELLY IN THE FOLEY TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22818724 ↗MalfunctionAug 7, 2025Short Fill; Short Fill
IT WAS REPORTED THAT THE SYRINGE IN THE FOLEY TRAY WAS NOT FILLED WITH STERILE WATER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22736094 ↗MalfunctionJul 10, 2025Component Missing; Component Missing
IT WAS REPORTED THAT THE FOLEY TRAY SYRINGE WAS NOT INCLUDED AND THERE ARE ONLY TWO COTTON BALLS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22469522 ↗MalfunctionJul 3, 2025Gel Leak; Gel Leak
IT WAS REPORTED THAT WHEN THE USER OPENED THE FOLEY TRAY, IT WAS STICKY, AND THE JELLY WAS TORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22394814 ↗MalfunctionJun 30, 2025Component Missing; Component Missing
IT WAS REPORTED THAT WHEN OPENED THE FOLEY TRAY PRODUCT, THE CATHETER JELLY IN THE TRAY WAS NOT THERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22357386 ↗MalfunctionJun 17, 2025Component Missing; Component Missing
IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING, POVIDONE WAS NOT INCLUDED IN THE FOLEY TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22234698 ↗MalfunctionJun 16, 2025Gel Leak; Gel Leak
IT WAS REPORTED THAT AFTER OPENING CATHETER JELLY'S PACKAGING WAS DAMAGED, BUT IT WAS STICKY. THERE WAS ALSO BLACK FOREIGN MATTER MIXED IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22211128 ↗MalfunctionJun 10, 2025Deflation Problem; Deflation Problem
IT WAS REPORTED THAT DURING PRETEST THE STERILE WATER COULD NOT BE DRAINED FROM THE FOLEY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22175675 ↗MalfunctionMay 30, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT IT WAS DIFFICULT TO DRAIN WATER. THE FOLEY CATHETER BALLOON WAS DIFFICULT TO DRAIN WATER AND TAKES A LONG TIME TO DEFLATE, SO THEY REFRAINED FROM USING IT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 16MAY2025, STATED THAT THERE WAS PATIENT INVOLVEMENT WITH NO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22114735 ↗MalfunctionMay 22, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE BLUE PLASTIC WRAP ON THE FOLEY CATHETER BODY WAS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069816 ↗MalfunctionApr 28, 2025Short Fill; Short Fill
IT WAS REPORTED THAT BEFORE USE, THE FOLEY TRAY HAD NO STERILE WATER IN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21917573 ↗
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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