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Device brand name · Indicator biological frc

Sterrad Cyclesure 24 Biological Indicator: medical device reports filed with FDA

890 reports name it, 2011–2017. Manufacturer given most often on reports: Advanced Sterilization Products. Product code FRC.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

890
device reports naming the brand: 0% of all MAUDE reports · about 57 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 100%
classified as malfunction: 91.6% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 890 reports that name the brand "Sterrad Cyclesure 24 Biological Indicator" (indicator biological frc), received between January 2011 and September 2017; the manufacturer given most often on reports is Advanced Sterilization Products. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (100%); across all indicator, biological sterilization process reports (product code FRC) death is recorded in 0% and malfunction in 91.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are chemical problem (33.5%), device operates differently than expected (16.7%) and device issue (0.8%). The patient problems coded most often are no patient involvement, bacterial infection and premature labor. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

No report naming Sterrad Cyclesure 24 Biological Indicator was received in the five years to August 2026; the latest was received in September 2017.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury0%0

Malfunction100%890

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%890

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 1,469 reports carrying product code FRC. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Chemical problem	298	33.5%	20.9%
Device operates differently than expectedthe device behaved unexpectedly	149	16.7%	12.3%
Device issuea problem with the device	7	0.8%	0.7%
Environmental particulates	7	0.8%	0.5%
Shelf life exceeded	5	0.6%	0.3%
Unable to obtain readings	5	0.6%	0.4%
Device disinfection or sterilization issue	4	0.4%	0.5%
Defective devicethe device was defective	3	0.3%	0.3%
Improper or incorrect procedure or method	3	0.3%	1.2%
Insufficient device problem information	2	0.2%	0.9%
Leak/splashthe device leaked	2	0.2%	0.7%
Chemical spillage	1	0.1%	0.1%
Contamination /decontamination problem	1	0.1%	0.5%
Device damaged prior to usethe device was damaged before use	1	0.1%	0.2%
Device sensing problem	1	0.1%	0.1%
Failure to disinfect	1	0.1%	0.1%
False positive result	1	0.1%	0.8%
Problem with sterilization	1	0.1%	0.3%
Product quality problem	1	0.1%	0.2%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
No patient involvement	469	52.7%
Bacterial infectiona bacterial infection	1	0.1%
Premature labor	1	0.1%
Skin discoloration	1	0.1%
Skin irritationirritated skin	1	0.1%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Sterrad Cyclesure 24 Biological Indicator	Product code FRC	All MAUDE reports
Reports	890	1,469	26,136,888
Share of that pool	—	60.6%	0%
Classified as death, per 1,000 reports	0	0	9
Classified as injury	0%	1.6%	36.2%
Classified as malfunction	100%	91.6%	62.3%
Filed by the manufacturer	100%	95.8%	94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code FRC

Brand	Reports	Latest 12 months	Classified as death
Cyclesure Biological Indicator	263	0	0%
Stryker	559	5	1.3%
Genesis	1,648	0	0.1%
Verify	2,413	8	0%
Sterrad Nx Sterilizer	1,006	0	0%
Sterrad 100s Sterilizer	1,162	0	0%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Sterrad Cyclesure 24 Biological Indicator reports

How many FDA reports name Sterrad Cyclesure 24 Biological Indicator?

890 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

chemical problem (33.5%), device operates differently than expected (16.7%), device issue (0.8%), environmental particulates (0.8%) and shelf life exceeded (0.6%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Sterrad Cyclesure 24 Biological Indicator was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.