AMSCO 16CRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00724995151928), received between Jul 13, 2022 and Mar 18, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 reports).

3 other recalls cover devices cleared under the same FDA submission (K111223, K212424); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR AMSCO C SERIES STERILIZER LEAKED WATER AND STEAM. PROCEDURES WERE CANCELLED AS A RESULT OF THIS EVENT. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627730 ↗
• MalfunctionJul 10, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR AMSCO C STERILIZER WAS LEAKING WATER ONTO THE FLOOR. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472120 ↗
• MalfunctionFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY CONTACTED STERIS REQUESTING FUNCTIONAL TESTING OF THEIR AMSCO C STERILIZER FOLLOWING A REPORT OF A PATIENT INFECTION.

  Patient problems: Eye Infections

  MAUDE report 21367383 ↗
• MalfunctionNov 21, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR WATER FEED LINE TO THE AMSCO C STERILIZER STEAM GENERATOR DETACHED CAUSING A WATER LEAK. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20748621 ↗
• MalfunctionOct 12, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR AMSCO C STERILIZER ONTO THE FLOOR. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919190 ↗
• MalfunctionJul 13, 2022Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED WATER WAS LEAKING FROM THEIR AMSCO C STERILIZER ONTO THE FLOOR. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15006105 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111223, K212424. One submission often covers many models, so check the product and lot details in each record.

• Z-0210-2016 · Sep 3, 2015 · Terminated
  AMSCO 400 and AMSCO C Small Steam Sterilizers
• Z-1561-2015 · Feb 19, 2015 · Terminated
  AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat
• Z-0915-2013 · Feb 12, 2013 · Terminated
  AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.