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Celerity LCB048Recalls & reported problems

Steris Corporation · The Celerity 20 STEAM Biological Indicator is a fast read 20-minute BI used for routine monitoring, qualification testing, load monitoring and product testing of commonly used steam sterilization cycles. · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10724995161542), received between Feb 17, 2022 and May 20, 2022 — classified as 2 malfunctions.

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
  • Leak/Splash1

Patient problems

  • Burn(s)1
  • Eye Pain1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 20, 2022Leak/Splash; Leak/Splash

    THE USER FACILITY REPORTED THAT AS AN EMPLOYEE OPENED A CELERITY 20 STEAM BI THE MEDIA SPLASHED INTO THEIR EYE RESULTING IN AN INJURY. MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED (EYE FLUSH).

    Patient problems: Eye Pain

    MAUDE report 14458873 ↗
  • MalfunctionFeb 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

    THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN WHILE HANDLING A CELERITY 20 STEAM BIOLOGICAL INDICATOR (BI). THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

    Patient problems: Burn(s)

    MAUDE report 13551693 ↗

Other Indicator, biological sterilization process devices

All Indicator, biological sterilization process devices →

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