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VERIFY Assert LCB033Recalls & reported problems

Steris Corporation · The VERIFY Assert STEAM Process Challenge Device for Dynamic Air Removal Cycles. · 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 10724995153035), received between Sep 1, 2022 and Sep 1, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1

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.

  • MalfunctionSep 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

    THE USER FACILITY REPORTED VIA MEDWATCH (MW5111090) THAT THEY RECEIVED "DRIED UP" CONTROL CONTAINERS AND THAT THEIR BIOLOGICAL TESTS HAVE BEEN FOUND DRY PRIOR TO AND AFTER PROCESSING. NO REPORT OF INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15335443 ↗

Other Indicator, biological sterilization process 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.