STERRAD™ 10104-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705037048700), received between Dec 7, 2018 and Jun 7, 2022 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Environmental Particulates” (9 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, 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿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 14621211 ↗
• MalfunctionMay 21, 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 14466086 ↗
• MalfunctionMay 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 SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285411 ↗
• MalfunctionDec 14, 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 13002715 ↗
• MalfunctionAug 4, 2021Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿WHITE SMOKE¿ OR HAZE EMITTING FROM THE STERRAD® 100 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 12277633 ↗
• MalfunctionMar 16, 2021Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A "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: Insufficient Information

  MAUDE report 11499357 ↗
• MalfunctionNov 24, 2020Smoking

  A CUSTOMER REPORTED AN "EXHAUST" OR SMOKE 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 10892058 ↗
• MalfunctionJul 13, 2020Gas/Air Leak

  A CUSTOMER REPORTED AN EVENT OF AN ODORLESS "MIST" OR HAZE EMITTING FROM THE STERRAD® 100NX STERILIZER FOR APPROXIMATELY TWO DAYS. TWO HEALTHCARE WORKERS (HCW¿S) EXPERIENCED REACTIONS OF NAUSEA, THROAT IRRITATION, COUGHING, HEADACHE AND COLD HANDS. ONE HEALTHCARE WORKER WHO HAS A HISTORY OF ASTHMA REPORTED RESPIRATORY SYMPTOMS; HOWEVER, THE SYMPTOMS RESOLVED WITH THEIR ASTHMA INHALER. THE HCW ALSO REPORTED A VERY SLIGHT "NOSE BLEED." THE HCWS DID NOT SEEK OR RECEIVE ANY MEDICAL ATTENTION/TREATMENT AND THE SYMPTOMS RESOLVED WITH OVER-THE-COUNTER MEDICATIONS. BOTH HCWS ARE REPORTED TO BE GOOD AND BOTH ARE BACK AT WORK. THE EVENT WAS INITIALLY REPORTED TO THE FACILITY ENGINEER ON ONSITE ON 6/17/2020, AND THE FACILITY ENGINEER SAID IT WAS ONLY STEAM AND ADVISED THE HCWS TO CONTINUE WORKING. THE FOLLOWING DAY THE FACILITY CONTACTED ASP, AND 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: Headache; Nausea; No Code Available; Skin Irritation

  MAUDE report 10267625 ↗
• MalfunctionJan 3, 2020Device 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 Consequences Or Impact To Patient

  MAUDE report 9547485 ↗
• MalfunctionDec 13, 2019Device 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 Consequences Or Impact To Patient

  MAUDE report 9469553 ↗
• MalfunctionJun 3, 2019Environmental 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 ADVISED TO TURN THE UNIT 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 Consequences Or Impact To Patient

  MAUDE report 8663523 ↗
• MalfunctionJan 4, 2019Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A "OIL MIST FILTER FAILURE" OR OIL 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 8219972 ↗
• MalfunctionDec 7, 2018Environmental 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 Consequences Or Impact To Patient

  MAUDE report 8142908 ↗