SYSTEM 1E Liquid Chemical Sterilant Processing SystemRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995092986), received between Apr 13, 2023 and Apr 13, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K090036, K101409, K102462, K113520, K131078, K161683, K170956, K180342, K190104, K192929, K210737, K211607, K222615, K232914, K251666); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2023Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED IRRITATION/INHALATION AFTER PLACING THE S40 STERILANT CONCENTRATE CONTAINER INTO THE STERILANT COMPARTMENT IN THE SYSTEM 1E AND INSERTING THE ASPIRATOR PROBE OVER THE STERILANT CONTAINER LID. THE EMPLOYEE WAS SENT TO THE ER AND RECEIVED A MEDICAL EXAM.

  Patient problems: Burning Sensation

  MAUDE report 16731420 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090036, K101409, K102462, K113520, K131078, K161683, K170956, K180342, K190104, K192929, K210737, K211607, K222615, K232914, K251666. One submission often covers many models, so check the product and lot details in each record.

• Z-1180-2016 · Dec 4, 2015 · Terminated
  Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapt
• Z-0616-2014 · Nov 21, 2013 · Terminated
  SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the
• Z-1596-2013 · Mar 4, 2013 · Terminated
  Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Re
• Z-2284-2012 · Aug 10, 2012 · Terminated
  QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
• Z-2335-2012 · Aug 1, 2012 · Terminated
  The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible
• Z-0869-2012 · Dec 7, 2011 · Terminated
  STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to
• Z-3124-2011 · Aug 11, 2011 · Terminated
  SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corporation, Mentor, OH 44060. Product Usage: The SYSTEM 1E Liqu
• Z-1960-2011 · Mar 14, 2011 · Terminated
  STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System The SYSTEM 1 E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manual