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MICROTEK 1 (UDI 00748426095575)Recalls & reported problems

Microtek Medical LLC · MICROSCOPE DRAPE FOR LEICA M720/OH5, 46 X 120, 1-EACH · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00748426095575), received between Dec 28, 2021 and Dec 28, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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

Device problems

  • Manufacturing, Packaging or Shipping Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 28, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    IT WAS REPORTED THAT THERE WAS A HAIR FOUND IN THE INTERIOR OF THE MICROSCOPE DRAPE PACKAGE WHILE SETTING UP THE DRAPE. NO PATIENT INFECTION, INJURY, OR COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13096687 ↗

Other Drape, surgical devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.