MICROTEK 1 (UDI 00748426107360)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00748426107360), received between Oct 16, 2023 and Apr 2, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE "THE LITTLE STICKER ON THE ADHESIVE STRIP CANNOT BE REMOVED. THE SMALL ADHESIVE SQUARE ON THE WHITE ADHESIVE STRIP (ADHESIVE STRIP LABELED MICROTEK ECOLAB ADHESION ) THE SECOND DRAWING ON THE COVER UNABLE TO REMOVE ADHESIVE FROM SURFACE". NO PATIENT INJURY, INFECTIONS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019028 ↗
• MalfunctionDec 19, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE STICKER THAT COVERS THE ADHESIVE PART OF THE PROBE IS COMING OFF VERY HARD AND DAMAGING THE PROBE COVER, ON THE ADHESIVE STRIP. THIS WAS DETECTED BY THE NURSE IN THE OR. NO PATIENT INJURY, INFECTIONS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18359780 ↗
• MalfunctionOct 16, 2023Material Puncture/Hole; Material Puncture/Hole

  ITR WAS REPORTED THAT THE STICKER ON THE PROBE COVER THAT EXPOSES THE ADHESIVE IS VERY TOUGH TO PULL OFF AND EITHER REMOVES THE ADHESIVE WITH THE STICKER OR ENDS UP RIPPING A HOLE IN THE PROBE COVER. NO PATIENT INJURY, INFECTIONS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17938478 ↗