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MICROTEK 1 (UDI 00748426011742)Recalls & reported problems

Microtek Medical LLC · SHOULDER ARTHROSCOPY DRAPE, 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 00748426011742), received between May 3, 2019 and May 3, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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

  • Defective Device1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionMay 3, 2019Defective Device

    APPEARS TO BE MANUFACTURING DEFECT IN PLACEMENT OF INSTRUCTIONAL DIAGRAM FOR STERILE APPLICATION. ECOLAB MICROTEK SHOULDER ARTHROSCOPY DRAPE REF #(B)(4), LOT #D183304 WAS DESIGNED SO THAT WHEN YOU DRAPE THE LOWER PART OF THE BODY, THE ADHESIVE PART OF THE DRAPE IS ON THE WRONG SIDE. IF YOU USE THE DIAGRAM ON THE DRAPE - YOU ARE PLACING UPSIDE DOWN

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8577310 ↗

Other Drape, surgical devices

All Drape, surgical devices →

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