Devices › Sterilizer, chemical
Device brand name · Sterrad equipment mlr
Sterrad 100nx Sterilizer: medical device reports filed with FDA
766 reports name it, 2008–2021. Manufacturer given most often on reports: Advanced Sterilization Products. Product code MLR.
- 766
- device reports naming the brand
- 0% of all MAUDE reports · about 43 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 97.9%
- classified as malfunction
- 90.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
766 medical device reports received by FDA name the brand "Sterrad 100nx Sterilizer" (sterrad equipment mlr); the manufacturer given most often on reports is Advanced Sterilization Products; received from September 2008 to March 2021. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (97.9%) and injury (2.1%); 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 (64.1%), environmental particulates (18.7%) and other (for use when an appropriate device code cannot be identified) (6.5%). The patient problems coded most often are no patient involvement, headache and burn(s). 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 100nx Sterilizer was received in the five years to August 2026; the latest was received in March 2021.
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 | 491 | 64.1% | 34.6% |
| Environmental particulates | 143 | 18.7% | 18.3% |
| Other (for use when an appropriate device code cannot be identified) | 50 | 6.5% | 19.9% |
| Chemical problem | 19 | 2.5% | 3.4% |
| Device disinfection or sterilization issue | 4 | 0.5% | 0.2% |
| Human-device interface problem | 4 | 0.5% | 0.7% |
| Component falling | 3 | 0.4% | 0.3% |
| Device-device incompatibility | 3 | 0.4% | 0.6% |
| Fogging | 3 | 0.4% | 0.5% |
| Fumes or vapors | 3 | 0.4% | 0.7% |
| Contamination /decontamination problem | 2 | 0.3% | 0.3% |
| Device damaged prior to usethe device was damaged before use | 2 | 0.3% | 0.3% |
| Component incompatible | 1 | 0.1% | 0.1% |
| Degraded | 1 | 0.1% | 0% |
| Device damaged by another device | 1 | 0.1% | 0% |
| Device handling problem | 1 | 0.1% | 1% |
| Device maintenance issue | 1 | 0.1% | 0.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.1% | 0.5% |
| Failure to cycle | 1 | 0.1% | 0% |
| Improper or incorrect procedure or method | 1 | 0.1% | 0.7% |
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 | 452 | 59% |
| Headachehead pain | 45 | 5.9% |
| Burn(s)a burn | 12 | 1.6% |
| Skin discoloration | 12 | 1.6% |
| Irritationirritation | 11 | 1.4% |
| Itching sensation | 9 | 1.2% |
| Nauseafeeling sick | 9 | 1.2% |
| Chemical exposure | 8 | 1% |
| Respiratory distressdifficulty breathing | 8 | 1% |
| Sore throat | 5 | 0.7% |
| Burning sensationa burning feeling | 4 | 0.5% |
| Skin irritationirritated skin | 4 | 0.5% |
| Dizzinesslight-headedness or unsteadiness | 3 | 0.4% |
| Swellingswelling | 3 | 0.4% |
| Chest painchest pain | 2 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sterrad 100nx Sterilizer | Product code MLR | All MAUDE reports |
|---|---|---|---|
| Reports | 766 | 5,244 | 26,136,888 |
| Share of that pool | — | 14.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 2.1% | 5% | 36.2% |
| Classified as malfunction | 97.9% | 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% |
| V-Pro Max Sterilizer | 188 | 2 | 0% |
| Sterrad 200 Single Door | 175 | 0 | 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 100nx Sterilizer reports
How many FDA reports name Sterrad 100nx Sterilizer?
766 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 (97.9%) and injury (2.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device emits odor (64.1%), environmental particulates (18.7%), other (for use when an appropriate device code cannot be identified) (6.5%), chemical problem (2.5%) and device disinfection or sterilization issue (0.5%). 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 100nx Sterilizer 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.