Devices › Sterilizer, chemical
Device brand name · Sterrad equipment mlr
Sterrad 200 Single Door: medical device reports filed with FDA
175 reports name it, 2012–2016. Manufacturer given most often on reports: Advanced Sterilization Products. Product code MLR.
- 175
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 97.1%
- classified as malfunction
- 90.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 175 reports that name the brand "Sterrad 200 Single Door" (sterrad equipment mlr), received between May 2012 and November 2016; 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 (97.1%) and injury (2.9%); across all sterilizer, chemical reports (product code MLR) death is recorded in 0.1% and malfunction in 90.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device emits odor (89.7%), device issue (0.6%) and device maintenance issue (0.6%). The patient problems coded most often are no patient involvement, headache and burning sensation. 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 200 Single Door was received in the five years to August 2026; the latest was received in November 2016.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 5,244 reports carrying product code MLR. 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 |
|---|---|---|---|
| Device emits odor | 157 | 89.7% | 34.6% |
| Device issuea problem with the device | 1 | 0.6% | 0.2% |
| Device maintenance issue | 1 | 0.6% | 0.1% |
| Fumes or vapors | 1 | 0.6% | 0.7% |
| Manufacturing, packaging or shipping problem | 1 | 0.6% | 0% |
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 | 132 | 75.4% |
| Headachehead pain | 14 | 8% |
| Burning sensationa burning feeling | 4 | 2.3% |
| Nauseafeeling sick | 3 | 1.7% |
| Skin irritationirritated skin | 2 | 1.1% |
| Headache, lumbar puncture | 1 | 0.6% |
| Irritationirritation | 1 | 0.6% |
| Skin discoloration | 1 | 0.6% |
| Sore throat | 1 | 0.6% |
| Tachycardiafast heart rate | 1 | 0.6% |
| Tingling | 1 | 0.6% |
| Tinnitusringing in the ears | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sterrad 200 Single Door | Product code MLR | All MAUDE reports |
|---|---|---|---|
| Reports | 175 | 5,244 | 26,136,888 |
| Share of that pool | — | 3.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 2.9% | 5% | 36.2% |
| Classified as malfunction | 97.1% | 90.5% | 62.3% |
| Filed by the manufacturer | 100% | 98.7% | 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 MLR
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Sterrad 100s Sterilizer | 1,162 | 0 | 0% |
| Sterrad Nx Sterilizer | 1,006 | 0 | 0% |
| Sterrad 100nx Sterilizer | 766 | 0 | 0% |
| V-Pro Max Sterilizer | 188 | 2 | 0% |
| Sterrad 200 Sterilization System | 153 | 0 | 0% |
| Sterrad Nx Sterilization System | 151 | 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 200 Single Door reports
How many FDA reports name Sterrad 200 Single Door?
175 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 (97.1%) and injury (2.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device emits odor (89.7%), device issue (0.6%), device maintenance issue (0.6%), fumes or vapors (0.6%) and manufacturing, packaging or shipping problem (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 200 Single Door 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.