CelerityRecalls & reported problems across all models

We found 5 models of Celerity by Steris Corporation in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between Feb 17, 2022 and Sep 18, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Celerity recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 3 of these models · Recall details · FDA record ↗

Most reported Celerity problems

Celerity models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Celerity LCB044

  Indicator, biological sterilization process
  1 recall4 reports
• Celerity LCB053

  Indicator, biological sterilization process
  1 recall2 reports
• Celerity LCB049

  Indicator, biological sterilization process
  1 recall1 report
• Celerity LCB048

  Indicator, biological sterilization process
  2 reports
• CELERITY PCC077

  Indicator, physical/chemical sterilization process
  1 report

Recent Celerity adverse event reports

The 10 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Insufficient Device Problem Information

  The user facility reported via MedWatch Report #0505900000-2026-8004 that, ¿Steris HP indicator tape ref PCC077 hit and missed changing the color afterexposure to low temperature sterilization.¿ No report of injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818420 ↗
• MalfunctionNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A POSITIVE BIOLOGICAL INDICATOR. THE INSTRUMENTS HAD TO BE REPROCESSED RESULTING IN A PROCEDURE DELAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20737852 ↗
• MalfunctionAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE WAS IN THE PROCESS OF ACTIVATING THE CELERITY 20 HP BIOLOGICAL INDICATOR AND OBSERVED "WHITE SPOTS" ON THEIR FINGERS. THE EMPLOYEE SOUGHT TREATMENT AND PLACED THEIR FINGERS IN WATER. THE EMPLOYEE WAS ALSO ADVISED TO APPLY OINTMENT (VASELINE).

  Patient problems: Skin Discoloration

  MAUDE report 17631820 ↗
• 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 ↗
• MalfunctionFeb 10, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VIA MEDWATCH REPORT MW5114138 THAT THERE WAS NO MEDIA IN THE CAP FOR BIOLOGICAL TESTING. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16358303 ↗
• 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 ↗
• MalfunctionOct 28, 2022Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A "BURN" AFTER HANDLING THEIR CELERITY 20 HP BIOLOGICAL INDICATOR. THE EMPLOYEE WASHED THEIR HANDS AND WENT TO THE ER.

  Patient problems: Burn(s)

  MAUDE report 15693195 ↗
• MalfunctionAug 31, 2022Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A "BURN" WHILE HANDLING THEIR BIOLOGICAL INDICATOR. THE EMPLOYEE SELF-TREATED BY RINSING THE BURN. IT IS UNKNOWN IF ADDITIONAL MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Burn(s)

  MAUDE report 15328003 ↗
• 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 Steris Corporation products

• V. Mueller118 models · 91 reports · 47 recalls
• Snowden-Pencer62 models · 83 reports · 16 recalls
• VERIFY11 models · 15 reports · 12 recalls
• HarmonyAIR240 models · 86 reports · 4 recalls
• ALYON26 models · 5 reports · 2 recalls