Lubri-Sil® I.C. Complete Care® Urine Meter Foley Tray 903114ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741046629), received between Dec 3, 2024 and Nov 4, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Component Missing” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT BEFORE USE, UPON OPENING IT WAS DISCOVERED THAT THE SYRINGE AND GAUZE WERE MISSING IN THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467451 ↗
• MalfunctionOct 27, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT FOLEY TRAY DID NOT INCLUDE THE CATHETER GEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23398893 ↗
• MalfunctionAug 18, 2025Component Missing; Incomplete or Missing Packaging; Component Missing; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE FOLEY TRAY STERILIZED CONTENTS ARE SPARSELY PACKAGED ACROSS MULTIPLE LOTS, MAKING THEM DIFFICULT TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827874 ↗
• MalfunctionJun 25, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING USE, THE FOLEY TRAY HAD NO COTTON BALLS INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331281 ↗
• MalfunctionApr 14, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN THEY OPENED THE PACKAGE TO USE IT, THEY FOUND A HAIR TANGLED IN THE INFLATION VALVE OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21832735 ↗
• MalfunctionApr 10, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRETEST, IT WAS DIFFICULTY IN DRAINING FROM THE FOLEY CATHETER. MEDICON SYRINGE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21813672 ↗
• MalfunctionDec 3, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT ON SEPTEMBER 2ND, DISTILLED WATER WAS INJECTED TO CHECK THE FOLEY CATHETER BALLOON BEFORE USE. THE BALLOON DID NOT RETURN EVEN WHEN THE SYRINGE WAS PULLED, AND ALTHOUGH WATER COULD BE INJECTED, IT COULD NOT BE PULLED, SO IT WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20831364 ↗