STERRAD™ 10104-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705037014507), received between Jun 1, 2018 and Jun 14, 2023 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Environmental Particulates” (16 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. 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2023Environmental Particulates; Environmental Particulates

  WHILE AT CUSTOMER SITE FOR A SEPARATE ISSUE, THE FIELD SERVICE ENGINEER REPORTED AN EVENT OF A ¿SMOKE¿ OR MIST/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 PREVIOUS SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17132010 ↗
• MalfunctionFeb 15, 2023Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF AN ¿OIL MIST¿ 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 16379858 ↗
• MalfunctionDec 29, 2022Device Emits Odor; Environmental Particulates; Device Emits Odor; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿MIST¿ OR VAPOR AND AN ¿INTENSE SMELL¿ OR ODOR EMITTING FROM THE STERRAD® 100NX STERILIZER, AND A HEALTH CARE WORKER (HCW) REPORTED EXPERIENCING A RESPIRATORY REACTION DESCRIBED AS A BURNING IN THE THROAT. THE RESPIRATORY REACTION DISAPPEARED WHEN THE HCW LEFT THE ROOM, AND NO MEDICAL TREATMENT WAS REQUIRED. LASTLY, THE HCW STATUS WAS REPORTED AS ¿IN GOOD HEALTH¿. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THE RESPIRATORY REACTION RESOLVED WITHOUT MEDICAL OR SURGICAL INTERVENTION AND WAS ASSESSED TO BE A MINOR INJURY; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 16072765 ↗
• MalfunctionDec 29, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿FOG¿ OR VAPOR/MIST EMITTING FROM THE STERRAD® 100NX STERILIZER, AND SEVEN HEALTH CARE WORKERS (HCWS) EXPERIENCED RESPIRATORY AND/OR EYE REACTIONS. FOUR HCWS REPORTED EYE REACTION WITH SYMPTOM OF ¿BURNING EYES¿, TWO HCWS REPORTED RESPIRATORY REACTION OF NASAL CONGESTION, AND ONE HCW REPORTED EXPERIENCING BOTH ¿BURNING EYES¿ AND NASAL CONGESTION. THE RESPIRATORY AND EYE REACTIONS DISAPPEARED WHEN THE HCWS LEFT THE ROOM, AND NO MEDICAL TREATMENT WAS REQUIRED. LASTLY, THE HCWS STATUS WAS REPORTED AS ¿IN GOOD HEALTH¿. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THE RESPIRATORY AND EYE REACTIONS RESOLVED WITHOUT MEDICAL OR SURGICAL INTERVENTION AND WERE ASSESSED TO BE MINOR INJURIES; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY FOR THE VAPOR/MIST ISSUE.

  Patient problems: Eye Burn

  MAUDE report 16068741 ↗
• MalfunctionSep 7, 2022Device Emits Odor; Device Emits Odor

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15371315 ↗
• MalfunctionJun 15, 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 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 14700878 ↗
• MalfunctionMay 19, 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. 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 14435554 ↗
• MalfunctionMay 18, 2022Environmental Particulates; Environmental Particulates

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428745 ↗
• MalfunctionApr 28, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿WHITE FOG¿ OR MIST/HAZE EMITTING FROM THE STERRAD® 100NX STERILIZER, AND A USER EXPERIENCED AN ¿EYE BURNING¿ REACTION. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THE EYE REACTION IS CONSIDERED MINOR AS THERE WAS NO REPORT OF MEDICAL TREATMENT; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

  Patient problems: Eye Burn

  MAUDE report 14246644 ↗
• MalfunctionApr 27, 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 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 14227924 ↗
• MalfunctionMar 25, 2022Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF AN ¿ODOR¿ OR SMELL EMITTING FROM THE STERRAD® 100NX STERILIZER. IT WAS REPORTED THAT FIVE HEALTH CARE WORKERS (HCWS) DETECTED THE ODOR AND EXPERIENCED MINOR RESPIRATORY AND/OR SKIN REACTIONS. ALL FIVE HCWS EXHIBITED SYMPTOMS OF RED, ITCHY RASH OVER THE ¿WHOLE BODY¿. IT WAS REPORTED THAT ALL FIVE HCWS WORE PPE OF MASKS, GOWNS, AND GLOVES, AND THEY EVACUATED THE ROOM TO HELP RESOLVE THE SYMPTOMS. HCW1 WAS UNLOADING FROM THE STERILIZER¿S CHAMBER AND EXPERIENCED AN ADDITIONAL AILMENT OF DYSPHONIA; THE DYSPHONIA RESOLVED IN 8 HOURS AND THE RASH WITH ERUPTIONS RESOLVED IN 24 HOURS, AND NO MEDICAL TREATMENT WAS REPORTED. HCW2 EXPERIENCED BREATHING DIFFICULTY AND A RASH WITH PAPULES; THE BREATHING DIFFICULTY RESOLVED IN 6 HOURS AND THE RASH RESOLVED IN 24 HOURS WITH NO MEDICAL TREATMENT REPORTED. THE REMAINING THREE HCWS ONLY EXPERIENCED THE SKIN REACTION OF RASH WITH ERUPTIONS; HOWEVER, THE CONDITION LASTED 5 DAYS AND WAS TREATED WITH AN OVER-THE-COUNTER (OTC) ORAL ANTIHISTAMINE LORATADINE. LASTLY, ALL FIVE HCWS WERE REPORTED TO HAVE RECOVERED. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THE INFORMATION SUGGESTS THE RESPIRATORY A

  Patient problems: Dyspnea; Itching Sensation; Rash; Sore Throat

  MAUDE report 13911559 ↗
• MalfunctionJan 14, 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 SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261631 ↗
• MalfunctionJan 7, 2022Environmental Particulates; Environmental Particulates

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196724 ↗
• MalfunctionOct 8, 2021Environmental 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 SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12601494 ↗
• MalfunctionMay 26, 2021Environmental 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 SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891328 ↗
• MalfunctionApr 7, 2021Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A "BURNING SMELL" (ODOR) EMITTING FROM THE STERRAD® 100NX STERILIZER WHILE RUNNING A CYCLE. 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: Insufficient Information

  MAUDE report 11629638 ↗
• MalfunctionMar 23, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A CYCLE CANCELLATION OF AN E14 ATM SWITCH ERROR WITH THEIR STERRAD® 100NX STERILIZER AND THE CANCELLED CYCLE WAS RELEASED FOR USE ON PATIENTS PRIOR TO REPROCESSING. THERE IS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, ASP HAS DECIDED TO REPORT ALL INCIDENTS OF LOADS THAT ARE RELEASED FROM CANCELLED CYCLES PRIOR TO REPROCESSING.

  Patient problems: Insufficient Information

  MAUDE report 11556335 ↗
• MalfunctionApr 15, 2020Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A "SMOKE" OR HAZE/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 SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9965112 ↗
• MalfunctionApr 9, 2020Device Emits Odor; Environmental Particulates; Device Emits Odor; 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 SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9946651 ↗
• MalfunctionJan 14, 2019Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF AN "OIL MIST FILTER FAILURE" 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 SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8245712 ↗
• MalfunctionOct 8, 2018Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A "STRONG SMELL OF OIL MIXED WITH PEROXIDE" 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 SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7945539 ↗
• MalfunctionJul 11, 2018Degraded; Environmental Particulates; Degraded; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF AN OIL MIST EMITTING FROM THE STERRAD® 100NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE CUSTOMER WAS ADVISED TO TURN THE UNIT OFF AND LEAVE 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 Consequences Or Impact To Patient

  MAUDE report 7678260 ↗
• MalfunctionJun 1, 2018Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A "STRONG ODOR OF PEROXIDE" 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 SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7563106 ↗

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.