STERRAD NX™ 10033Recalls & reported problems

Summary

The FDA's MAUDE database contains 132 adverse event reports that list this exact device (DI 10705037014132), received between Mar 12, 2018 and Sep 5, 2023 — classified as 132 malfunctions.

The most frequently reported specific device problem is “Device Emits Odor” (77 reports).

11 other recalls cover devices cleared under the same FDA submission (K042116, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 132 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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® 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 16432658 ↗
• MalfunctionDec 29, 2022Device Emits Odor; Device Emits Odor

  WHILE ONSITE AT THE CUSTOMER FACILITY FOR A SEPARATE ISSUE, THE ASP FIELD SERVICE ENGINEER NOTED AN ¿ODOR¿ OR SMELL 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 16074978 ↗
• MalfunctionNov 18, 2022Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A ¿SMELL¿ OR ODOR EMITTING FROM THE STERRAD® NX STERILIZER THAT STARTED SINCE ON (B)(6) 2022. 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 15822119 ↗
• MalfunctionOct 21, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR MIST 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 15655105 ↗
• MalfunctionOct 4, 2022Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A ¿STRONG SMELL¿ OR ODOR EMITTING FROM THE STERRAD® NX STERILIZER, AND A HEALTH CARE WORKER (HCW) EXPERIENCED EYE IRRITATION AND A HEADACHE. IT WAS REPORTED THE SYMPTOMS RESOLVED IN APPROXIMATELY 1.5 HOURS WITH NO MEDICAL TREATMENT RECEIVED, AND THE HCW STATUS WAS NOTED AS "FINE¿. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THE REPORTED INJURIES RESOLVED WITHOUT MEDICAL TREATMENT AND WERE DEEMED TO BE MINOR; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

  Patient problems: Eye Irritation; Headache

  MAUDE report 15540111 ↗
• MalfunctionOct 3, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR HAZE EMITTING FROM THE STERRAD® NX STERILIZER. THE CUSTOMER DISCONTINUED USE OF THE UNIT AND EVACUATED THE AREA. 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 15531757 ↗
• MalfunctionSep 24, 2022Device Emits Odor; Device Emits Odor

  AN ASP REPRESENTATIVE REPORTED AN EVENT OF AN ODOR/SMELL EMITTING FROM THE STERRAD® NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE REPRESENTATIVE 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 15481116 ↗
• MalfunctionSep 15, 2022Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A ¿STRANGE 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 SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15428715 ↗
• MalfunctionSep 9, 2022Environmental Particulates; Environmental Particulates

  WHILE ON SITE FOR A SEPARATE ISSUE, THE ASP FIELD SERVICE ENGINEER OBSERVED A SMOKE/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 SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396430 ↗
• MalfunctionSep 8, 2022Device 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 SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380412 ↗
• MalfunctionSep 7, 2022Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A ¿BURNT OIL 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 SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375084 ↗
• MalfunctionSep 1, 2022Device 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. THE CUSTOMER STATED THEY 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 15338173 ↗
• MalfunctionAug 26, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR HAZE EMITTING FROM THE STERRAD® NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. A 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 15303559 ↗
• MalfunctionAug 26, 2022Device Emits Odor; Device Emits Odor

  WHILE ONSITE FOR A SEPARATE ISSUE, THE FIELD SERVICE ENGINEER NOTED A ¿HAZE¿ OR MIST 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 SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303465 ↗
• MalfunctionAug 18, 2022Device 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 SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15252861 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042116, 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-0845-2015 · Nov 4, 2014 · Terminated
  STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and mois
• Z-0744-2014 · Dec 16, 2013 · Terminated
  STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inac
• Z-0403-2014 · Nov 11, 2013 · Terminated
  STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical de
• Z-2338-2012 · Jun 19, 2012 · Terminated
  STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sen
• Z-1420-2009 · Mar 9, 2009 · Terminated
  STERRAD NX Sterilization System Product Code 10033 The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive r
• Z-0468-2012 · Dec 10, 2008 · Terminated
  STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer Product Code 10133. The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterili
• Z-0484-2009 · Oct 7, 2008 · Terminated
  STERRAD NX Sterilizer, Product Code 10033 Low temperature sterilizers that use hydrogen peroxide gas plasma to inactivate microorganisms on a broad range of medical and surgical i
• Z-1631-2008 · Feb 25, 2008 · Terminated
  STERRAD NX Sterilizer, Product Code 10033 Used to sterilize heat and moisture sensitive reusable medical devices.
• Z-0844-2008 · Nov 12, 2007 · Terminated
  STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers, Document Numbers 15-53229 & 15-53230; STERRAD NX Sterilizers Compatible Medi