Integrity Sterilizers INTEGRITY 270Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841736100117), received between May 8, 2019 and Oct 4, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

1 other recall cover devices cleared under the same FDA submission (K132439); they may or may not involve this specific model.

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

Recent adverse event reports

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

• MalfunctionOct 4, 2021Detachment of Device or Device Component; Loose or Intermittent Connection; Detachment of Device or Device Component

  SKYTRON FIELD SERVICE TECHNICIAN SUBMITTED COMPLAINT ALLEGING THAT THE COTTER PINS THAT HOLDS THE WHEEL ASSEMBLY TOGETHER ON THE INTEGRITY 270 STERILIZER CARRIAGE RACK WERE COMING LOOSE. IF A WHEEL COMES OFF THE RACK THERE IS A RISK OF THE RACK TIPPING AND CONTENTS FALLING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12571611 ↗
• MalfunctionMay 8, 2019Crack; Crack

  THE COMPANY BECAME AWARE OF TWO INCIDENTS OUTSIDE OF THE USA WITH THE STEAM STERILIZER. THE FIRST INCIDENT WAS IN (B)(6) 2017 AND THE SECOND WAS (B)(6) 2017. A WELD ATTACHING THE AIR HEATER/FILTER ASSEMBLY TO THE MAIN STERILIZER UNIT SHOWED SIGNS OF FATIGUE. THE AFFECTED STEAM STERILIZER MODEL IS ONLY AVAILABLE IN (B)(6), HOWEVER THE COMPANY'S US MODEL, SKYTRON INTEGRITY 270, UTILIZES A SIMILAR AIR HEATER/FILTER ASSEMBLY. THE AIR HEATER/FILTER ASSEMBLY SUPPLIES HEATED FRESH AIR INTO THE CHAMBER AFTER THE STERILIZATION AND DRYING PROCESS HAS BEEN COMPLETED. THIS ALLOWS THE CHAMBER TO EQUALIZE TO ATMOSPHERIC PRESSURE PERMITTING THE USER TO OPEN THE CHAMBER AND UNLOAD THE UNITS. IF THERE IS A FAILURE TO THE WELD, THE CHAMBER PRESSURE WOULD STILL EQUALIZE AT THE END OF THE STERILIZATION AND DRYING CYCLE, BUT THE ROOM AIR MAY NOT GO THROUGH THE FILTER. THERE HAS BEEN NO INSTANCES OF FATIGUE OR FAILURE IN THE USA.

  Patient problems: No Patient Involvement

  MAUDE report 8591145 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132439. One submission often covers many models, so check the product and lot details in each record.

• Z-1779-2019 · Apr 18, 2019 · Terminated
  Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity