SEALSURE™ 14202Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705037016204), received between Mar 29, 2019 and Nov 13, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2020Defective Device

  A CUSTOMER REPORTED THE STERRAD® SEALSURE CHEMICAL INDICATOR TAPE DID NOT CHANGE COLOR CORRECTLY AFTER A COMPLETED STERRAD® 100S CYCLE AND THE AFFECTED LOAD WAS RELEASED FOR USE ON PATIENTS PRIOR TO REPROCESSING. THERE IS 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® SEALSURE CHEMICAL INDICATOR TAPE NOT CHANGING COLOR CORRECTLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10836858 ↗
• MalfunctionJul 29, 2019Chemical Problem; Chemical Problem

  A CUSTOMER REPORTED THE STERRAD® SEALSURE CHEMICAL INDICATOR TAPE DID NOT CHANGE COLOR CORRECTLY AFTER A COMPLETED STERRAD® 100S CYCLE AND THE AFFECTED LOAD WAS RELEASED FOR USE ON PATIENTS PRIOR TO REPROCESSING. THE AFFILIATE DID CONFIRM, HOWEVER, THAT THE CI ON THE BIOLOGICAL INDICATOR CHANGED CORRECTLY. THERE IS 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® SEALSURE CHEMICAL INDICATOR TAPE NOT CHANGING COLOR CORRECTLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8839629 ↗
• MalfunctionMar 29, 2019Chemical Problem; Chemical Problem

  A CUSTOMER INITIALLY REPORTED THE STERRAD® SEALSURE CHEMICAL INDICATOR TAPE DID NOT CHANGE COLOR CORRECTLY AFTER A COMPLETED STERRAD® 100S CYCLE. AT THE TIME OF THE REPORT, IT WAS UNKNOWN WHETHER OR NOT THE AFFECTED LOAD WAS RELEASED FOR USE ON PATIENTS PRIOR TO REPROCESSING. UPON FOLLOW-UP WITH THE CUSTOMER ON (B)(6) 2019, IT WAS DETERMINED THE LOAD WAS RELEASED FOR USE WITHOUT REPROCESSING FIRST. THERE IS 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® SEALSURE CHEMICAL INDICATOR TAPE NOT CHANGING COLOR CORRECTLY WHEN THE LOAD IS RELEASED FOR USE WITHOUT REPROCESSING FIRST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8466848 ↗
• MalfunctionMar 29, 2019Chemical Problem; Chemical Problem

  A CUSTOMER INITIALLY REPORTED THE STERRAD® SEALSURE CHEMICAL INDICATOR TAPE DID NOT CHANGE COLOR CORRECTLY AFTER A COMPLETED STERRAD® 100S CYCLE. AT THE TIME OF THE REPORT, IT WAS UNKNOWN WHETHER OR NOT THE AFFECTED LOAD WAS RELEASED FOR USE ON PATIENTS PRIOR TO REPROCESSING. UPON FOLLOW-UP WITH THE CUSTOMER ON (B)(6) 2019, IT WAS DETERMINED THE LOAD WAS RELEASED FOR USE WITHOUT REPROCESSING FIRST. THERE IS 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® SEALSURE CHEMICAL INDICATOR TAPE NOT CHANGING COLOR CORRECTLY WHEN THE LOAD IS RELEASED FOR USE WITHOUT REPROCESSING FIRST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8464847 ↗