CyclesureRecalls & reported problems across all models
Advanced Sterilization Products Services Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 75
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of Cyclesure by Advanced Sterilization Products Services Inc. in the FDA's device registry (GUDID). Together they are named in 75 adverse event reports in the FDA's MAUDE database, received between Apr 7, 2017 and May 15, 2020 — classified as 75 malfunctions.
The most frequently reported specific device problem is “Problem with Sterilization” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Cyclesure problems
Device problems
- Appropriate Device Problem Term/Code Not Available74
- Problem with Sterilization1
Patient problems
- No Known Impact Or Consequence To Patient55
- No Consequences Or Impact To Patient20
- No Patient Involvement2
- Fever1
Cyclesure models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Cyclesure 14324Indicator, biological sterilization process74 reports
- Cyclesure 14324-30Indicator, biological sterilization process1 report
Recent Cyclesure adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2020Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100S CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. 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 POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10063559 ↗MalfunctionMay 5, 2020Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100NX CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE PREVIOUS AND SUBSEQUENT BI RESULTS WERE BOTH NEGATIVE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. 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 POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10025058 ↗MalfunctionApr 30, 2020Problem with Sterilization
A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100NX CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE PREVIOUS AND SUBSEQUENT BI RESULTS WERE BOTH NEGATIVE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. 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 POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10015065 ↗MalfunctionApr 30, 2020Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100NX CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE TWO SUBSEQUENT BI RESULTS WERE BOTH NEGATIVE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. 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 POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10014447 ↗MalfunctionApr 27, 2020Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® NX CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. 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 POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10001864 ↗MalfunctionApr 27, 2020Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100NX FLEX CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. 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 POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10001858 ↗MalfunctionApr 2, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100NX CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. 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 POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9918980 ↗MalfunctionMar 30, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® CYCLE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. 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 POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9898407 ↗MalfunctionMar 17, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® NX CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE PREVIOUS AND SUBSEQUENT BI RESULTS WERE BOTH NEGATIVE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. 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 POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9843060 ↗MalfunctionMar 11, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100S CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE PREVIOUS AND SUBSEQUENT BI RESULTS WERE BOTH NEGATIVE. THE AFFECTED LOAD WAS PARTIALLY RELEASED AND USED ON A PATIENT. 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 POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9818853 ↗MalfunctionJan 2, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100S CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE SUBSEQUENT BI RESULTS WERE NEGATIVE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. 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 POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9541230 ↗MalfunctionJan 2, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100S CYCLE. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE AFFECTED LOAD WAS REPROCESSED PRIOR TO RELEASE EXCEPT ONE ITEM WAS RELEASED AND USED ON A PATIENT. 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 POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9540377 ↗MalfunctionDec 26, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100S CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE TWO SUBSEQUENT BI RESULTS WERE BOTH NEGATIVE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. 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 POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9521838 ↗MalfunctionDec 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® CYCLE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. 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 POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9399099 ↗MalfunctionDec 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® CYCLE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. 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 POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9399030 ↗
Other Advanced Sterilization Products Services Inc. products
All Advanced Sterilization Products Services Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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