STERRAD™ 14100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705037016198), received between May 23, 2018 and Feb 1, 2019 — classified as 2 malfunctions.

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

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.

• MalfunctionFeb 1, 2019Chemical Problem; Improper Chemical Reaction; Chemical Problem; Improper Chemical Reaction

  A CUSTOMER REPORTED A STERRAD® CHEMICAL INDICATOR STRIP DID NOT CHANGE COLOR CORRECTLY AFTER A COMPLETED STERRAD® 100NX EXPRESS CYCLE AND INDICATED THIS HAPPENED ON EIGHT DIFFERENT CYCLES/LOADS. ALL LOADS WERE RECALLED EXCEPT ONE WHICH WAS RELEASED AND USED ON ONE PATIENT. THE CI STRIPS WERE PLACED INSIDE AESCULAP TRAYS AND THERE WAS NO OVERLAPPING INSIDE THE TRAY. THE CI STRIPS ARE KEPT IN THE ORIGINAL BOTTLE AND STORED IN ANOTHER ROOM. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF STERRAD® CHEMICAL INDICATOR STRIPS NOT CHANGING COLOR CORRECTLY WHEN THE LOAD HAS BEEN RELEASED WITHOUT REPROCESSING FIRST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8299535 ↗
• MalfunctionMay 23, 2018Device Disinfection Or Sterilization Issue; Device Operates Differently Than Expected; Device Disinfection Or Sterilization Issue; Device Operates Differently Than Expected

  A CUSTOMER REPORTED A STERRAD® CHEMICAL INDICATOR STRIP DID NOT CHANGE COLOR CORRECTLY AFTER A COMPLETED STERRAD® NX CYCLE. THE CUSTOMER STATED THERE ARE "WHITE SPOTS" ON THE CHEMICAL INDICATOR STRIP AFTER THE CYCLE COMPLETION. THE AFFECTED LOAD WAS RELEASED FOR USE ON PATIENTS PRIOR TO REPROCESSING. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF STERRAD® CHEMICAL INDICATOR STRIPS NOT CHANGING COLOR CORRECTLY WHEN THE LOADS HAVE NOT BEEN REPROCESSED PRIOR TO RELEASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7538901 ↗