STERRAD™ 10104-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 10705037047581), received between Aug 2, 2018 and Sep 14, 2023 — classified as 2 injuries, 90 malfunctions.

The most frequently reported specific device problem is “Environmental Particulates” (48 reports).

8 other recalls cover devices cleared under the same FDA submission (K071385, K092622, K111377, K142454); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2023Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF AN ¿OILY SMELL¿ OR ODOR EMITTING FROM THE STERRAD® 100NX 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 17751247 ↗
• MalfunctionAug 16, 2023Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF AN ¿ODOR¿ OR SMELL EMITTING FROM THE STERRAD® 100NX STERILIZER. THE CUSTOMER STATED THAT 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 17561521 ↗
• MalfunctionJul 26, 2023Device Emits Odor; Environmental Particulates; Device Emits Odor; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF AN ¿ODOR¿ OR SMELL AND "SMOKE" OR HAZE EMITTING FROM THE STERRAD® 100NX STERILIZER THAT HAD BEEN OCCURRING FOR APPROXIMATELY TWO WEEKS. 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 17401535 ↗
• MalfunctionJul 25, 2023Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A ¿BURNING SMELL¿ OR ODOR EMITTING FROM THE STERRAD® 100NX 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 17389293 ↗
• MalfunctionJul 12, 2023Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A ¿SMELL¿ OR ODOR EMITTING FROM THE STERRAD® 100NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ON SITE. 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 17312231 ↗
• MalfunctionMay 31, 2023Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF AN ¿ODOR¿ OR SMELL EMITTING FROM THE STERRAD® 100NX STERILIZER, AND A HEALTH CARE WORKER (HCW) EXPERIENCED A HEADACHE. IT WAS REPORTED THAT ¿THE HEADACHE PASSED WITHIN A MOMENT,¿ AND THE HCW DID NOT REQUIRE TREATMENT. THE CUSTOMER WAS INSTRUCTED TO POWER OFF THE UNIT AND DISCONTINUE USE. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THE REPORTED SYMPTOM WAS DEEMED TO BE MINOR SINCE IT RESOLVED WITHOUT TREATMENT; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

  Patient problems: Headache

  MAUDE report 17032479 ↗
• MalfunctionApr 28, 2023Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF AN ¿ODOR¿ OR SMELL EMITTING FROM THE STERRAD® 100NX 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 16832263 ↗
• MalfunctionApr 25, 2023Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿HAZE¿ OR MIST EMITTING FROM THE STERRAD® 100NX 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 16808618 ↗
• MalfunctionApr 7, 2023Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF AN ¿ODOR¿ OR SMELL EMITTING FROM THE STERRAD® 100NX 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 16702595 ↗
• MalfunctionMar 8, 2023Environmental Particulates; Environmental Particulates

  WHILE ON SITE FOR A SEPARATE ISSUE, AN ASP FIELD SERVICE ENGINEER OBSERVED A ¿HAZE¿ OR MIST EMITTING FROM THE STERRAD® 100NX 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 16504556 ↗
• MalfunctionFeb 23, 2023Device Emits Odor; Environmental Particulates; Device Emits Odor; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF AN ODOR/SMELL AND MIST/HAZE EMITTING FROM THE STERRAD® 100NX 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 16432939 ↗
• MalfunctionFeb 10, 2023Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR MIST EMITTING FROM THE STERRAD® 100NX 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 16352918 ↗
• MalfunctionDec 8, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR VAPOR EMITTING FROM THE STERRAD® 100NX 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 15946747 ↗
• MalfunctionDec 5, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR HAZE EMITTING FROM THE STERRAD® 100NX 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 15921118 ↗
• MalfunctionJul 22, 2022Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF AN ODOR OR SMELL EMITTING FROM THE STERRAD® 100NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE CUSTOMER STATED THE UNIT HAD BEEN POWERED OFF. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089657 ↗
• MalfunctionJul 22, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿FOG¿ OR MIST/HAZE EMITTING FROM THE STERRAD® 100NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE CUSTOMER WAS INSTRUCTED TO EVACUATE THE AREA. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089611 ↗
• MalfunctionMay 27, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A MIST/HAZE EMITTING FROM THE STERRAD® 100NX STERILIZER 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 SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14523420 ↗
• MalfunctionMay 4, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR HAZE EMITTING FROM THE STERRAD® 100NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE CUSTOMER POWERED OFF THE UNIT AND DISCONTINUED 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 SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14272800 ↗
• MalfunctionApr 26, 2022Device Emits Odor; Environmental Particulates; Device Emits Odor; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR HAZE AND ¿ODOR¿ OR SMELL EMITTING FROM THE STERRAD® 100NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE CUSTOMER WAS INSTRUCTED TO POWER OFF THE UNIT AND EVACUATE THE AREA. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14209004 ↗
• MalfunctionApr 20, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿FOG¿ OR MIST/HAZE EMITTING FROM THE STERRAD® 100NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE CUSTOMER WAS INSTRUCTED EVACUATE THE ROOM. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14161193 ↗
• MalfunctionApr 20, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿FOG¿ OR MIST/HAZE EMITTING FROM THE STERRAD® 100NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE CUSTOMER WAS INSTRUCTED TO EVACUATE THE ROOM. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14160928 ↗
• MalfunctionApr 8, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿VAPOR¿ OR MIST EMITTING FROM THE STERRAD® 100NX 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 SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14061552 ↗
• MalfunctionMar 28, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿MIST¿ OR VAPOR EMITTING FROM THE STERRAD® 100NX 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 SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13930510 ↗
• MalfunctionMar 4, 2022Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF AN ¿ODOR¿ OR SMELL EMITTING FROM THE STERRAD® 100NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ON SITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13674790 ↗
• MalfunctionMar 3, 2022Environmental Particulates; Environmental Particulates

  WHILE ON SITE FOR A DIFFERENT ISSUE, ASP FIELD SERVICE ENGINEER OBSERVED A ¿SMOKE¿ OR HAZE EMITTING FROM THE STERRAD® 100NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664084 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071385, K092622, K111377, K142454. One submission often covers many models, so check the product and lot details in each record.

• Z-1197-2017 · Jan 9, 2017 · Terminated
  STERRAD NX Sterilization System, Product Code: 10033, 10033-002
• Z-2375-2015 · Jul 17, 2015 · Terminated
  Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.
• Z-0846-2015 · Nov 4, 2014 · Terminated
  STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and m
• Z-0402-2014 · Nov 11, 2013 · Terminated
  STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical
• Z-0044-2014 · Sep 18, 2013 · Terminated
  STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
• Z-2174-2013 · Jul 25, 2013 · Terminated
  STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusabl
• Z-1026-2013 · Mar 22, 2013 · Terminated
  STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX p
• Z-1632-2008 · Feb 25, 2008 · Terminated
  STERRAD 100NX Sterilizer, Product Code 10104 Used to sterilize heat and moisture sensitive reusable medical devices.