Celerity LCB053Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10724995161566), received between Jan 4, 2023 and Mar 30, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 25, 2022Open, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1793-2022 · Root cause: Environmental control · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionMar 30, 2023Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT THEIR CELERITY 20 STEAM PROCESS CHALLENGE DEVICE CONTAINED A DRY BIOLOGICAL INDICATOR WHICH WAS "AFFECTING THE CASELOADS AND PATIENT CARE" FOR THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645856 ↗
• MalfunctionJan 4, 2023Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT THEIR CELERITY 20 STEAM PROCESS CHALLENGE DEVICE BIOLOGICAL INDICATOR WAS DRY FOLLOWING A PROCESSING CYCLE. THE INSTRUMENT SUBJECT OF THE LOAD WAS REPROCESSED PRIOR TO USE RESULTING IN A PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16098629 ↗