STERRAD NXRecalls & 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
- 147
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of STERRAD NX by Advanced Sterilization Products Services Inc. in the FDA's device registry (GUDID). Together they are named in 147 adverse event reports in the FDA's MAUDE database, received between Mar 12, 2018 and Sep 6, 2023 — classified as 147 malfunctions.
The most frequently reported specific device problem is “Device Emits Odor” (83 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. 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 STERRAD NX problems
Device problems
- Device Emits Odor83
- Environmental Particulates71
- Smoking6
- Appropriate Device Problem Term/Code Not Available4
- Degraded1
- Fluid/Blood Leak1
- Therapeutic or Diagnostic Output Failure1
- Thermal Decomposition of Device1
Patient problems
- No Consequences Or Impact To Patient79
- No Clinical Signs, Symptoms or Conditions60
- Headache3
- No Code Available2
- Burning Sensation1
- Eye Irritation1
- Insufficient Information1
- Itching Sensation1
STERRAD NX models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- STERRAD NX™ 10033Sterilizer, chemical132 reports
- STERRAD NX™ 10033-004Sterilizer, chemical15 reports
Recent STERRAD NX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 6, 2023Environmental Particulates; Environmental Particulates
A CUSTOMER REPORTED AN EVENT OF A ¿MIST¿ OR HAZE EMITTING FROM THE STERRAD® NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17694909 ↗MalfunctionSep 5, 2023Device Emits Odor; Device Emits Odor
A CUSTOMER REPORTED AN EVENT OF A ¿SMELL¿ OR ODOR EMITTING FROM THE STERRAD® NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17686137 ↗MalfunctionAug 22, 2023Environmental Particulates; Environmental Particulates
A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR MIST/HAZE EMITTING FROM THE STERRAD® NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17600213 ↗MalfunctionAug 4, 2023Environmental Particulates; Environmental Particulates
WHILE AT CUSTOMER SITE FOR A PREVENTIVE MAINTENANCE, A FIELD SERVICE ENGINEER REPORTED A ¿SMOKE¿ OR MIST/HAZE EMITTING FROM THE STERRAD® NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17459750 ↗MalfunctionJul 25, 2023Device Emits Odor; Device Emits Odor
A CUSTOMER REPORTED AN EVENT OF AN ¿ODOR¿ OR SMELL EMITTING FROM THE STERRAD® NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17392698 ↗MalfunctionJul 11, 2023Device Emits Odor; Device Emits Odor
A CUSTOMER REPORTED AN EVENT OF AN ¿ODOR¿ OR SMELL EMITTING FROM THE STERRAD® NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE CUSTOMER WAS INSTRUCTED TO POWER OFF THE UNIT AND DISCONTINUE USE. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17301285 ↗MalfunctionJul 7, 2023Device Emits Odor; Device Emits Odor
A CUSTOMER REPORTED AN EVENT OF A ¿SMELL¿ OR ODOR EMITTING FROM THE STERRAD® NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17280063 ↗MalfunctionJun 30, 2023Environmental Particulates; Environmental Particulates
A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR MIST/HAZE EMITTING FROM THE STERRAD® NX STERILIZER THAT HAD BEEN OCCURRING FOR APPROXIMATELY TWO WEEKS. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE CUSTOMER WAS INSTRUCTED TO POWER OFF THE UNIT AND DISCONTINUE USE. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17242738 ↗MalfunctionJun 28, 2023Device Emits Odor; Device Emits Odor
A CUSTOMER REPORTED AN EVENT OF A ¿SMELL¿ OR ODOR EMITTING FROM THE STERRAD® NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE CUSTOMER WAS INSTRUCTED TO POWER OFF THE UNIT AND DISCONTINUE USE. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17218568 ↗MalfunctionMay 15, 2023Device Emits Odor; Device Emits Odor
A CUSTOMER REPORTED AN EVENT OF A ¿SMELL¿ OR ODOR EMITTING FROM THE STERRAD® NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931782 ↗MalfunctionMay 4, 2023Device Emits Odor; Device Emits Odor
A CUSTOMER REPORTED AN EVENT OF AN ¿ODOR¿ OR SMELL EMITTING FROM THE STERRAD® NX STERILIZER. THE CUSTOMER STATED THEY POWERED OFF THE UNIT AND DISCONTINUED USE. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16873326 ↗MalfunctionApr 28, 2023Environmental Particulates; Environmental Particulates
A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR MIST/HAZE EMITTING FROM THE STERRAD® NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE CUSTOMER WAS INSTRUCTED TO POWER OFF THE UNIT AND DISCONTINUE USE. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16829590 ↗MalfunctionApr 20, 2023Environmental Particulates; Environmental Particulates
WHILE AT CUSTOMER SITE FOR A SEPARATE ISSUE, THE FIELD SERVICE ENGINEER REPORTED AN EVENT OF A ¿MIST¿ OR HAZE EMITTING FROM THE STERRAD® NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16782041 ↗MalfunctionApr 20, 2023Environmental Particulates; Environmental Particulates
WHILE ON SITE FOR A PLANNED MAINTENANCE, THE FIELD SERVICE ENGINEER REPORTED A ¿SMOKE¿ OR HAZE EMITTING FROM THE STERRAD® NX STERILIZER AFTER SERVICE. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16781981 ↗MalfunctionApr 5, 2023Device Emits Odor; Device Emits Odor
A CUSTOMER REPORTED AN EVENT OF A ¿STRONG ODOR¿ OR SMELL EMITTING FROM THE STERRAD® NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16684068 ↗
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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