STERRAD™ 10104-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 10705037048694), received between Mar 2, 2018 and Aug 27, 2024 — classified as 2 injuries, 151 malfunctions.

The most frequently reported specific device problem is “Environmental Particulates” (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, 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 153 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2024Device Handling Problem; Device Handling Problem

  A CUSTOMER REPORTED A MALE HEALTH CARE WORKER (HCW) EXPERIENCED AN INJURY TO THE LEFT RING FINGER WHILE ATTEMPTING TO PLACE A USED VELOCITY BIOLOGICAL INDICATOR INSIDE THE STERRAD® 100NX STERILIZER CHAMBER AS THE DOOR WAS CLOSING, AND HE CLAIMED THE SAFETY FEATURE ON THE DOOR DID NOT FUNCTION PROPERLY. AFTER THIS EVENT OCCURRED, THE CUSTOMER CONFIRMED USE ERROR. THE SUPERVISOR REPORTED THE HCW WAS RETRAINED TO NOT PUT HIS HAND IN THE CHAMBER OF THE UNIT WHEN THE DOOR IS IN THE PROCESS OF CLOSING. OTHER USE ERROR WAS ALSO IDENTIFIED, AND THE HCW WAS RETRAINED ON THE CORRECT PROCEDURE AS PER THE STERRAD® 100NX USER GUIDE. HCW DID NOT SEEK MEDICAL ATTENTION ON THE DAY OF THE EVENT BUT VISITED THE EMERGENCY ROOM (ER) THE DAY AFTER BECAUSE THE AFFECTED AREA BECAME SWOLLEN AND PURPLE. X-RAYS WERE TAKEN IN THE ER, AND HE WAS DIAGNOSED WITH CRUSHING INJURY OF FINGER, SUBUNGUAL HEMATOMA, AND CLOSED FRACTURE OF TUFT OF DISTAL PHALANX OF FINGER. THE AFFECTED AREA WAS SPLINTED IN THE ER. HCW REPORTED HE TOOK A COUPLE OF DAYS OFF WORK AND WAS PLACED ON "LIGHT RESTRICTION" BY OCCUPATIONAL HEALTH. HE RETURNED TO WORK ON JUNE 4, 2024. NINE DAYS AFTER THE EVENT, HCW REPORTED THE PURPLE AREA ON FING

  Patient problems: Bone Fracture(s); Hematoma; Pain; Swelling/ Edema

  MAUDE report 20081752 ↗
• MalfunctionSep 25, 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. 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 17808144 ↗
• MalfunctionSep 14, 2023Device Emits Odor; Environmental Particulates; Device Emits Odor; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF AN ¿ODOR¿ OR SMELL AND A ¿SMOKE¿ OR 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 17742454 ↗
• MalfunctionSep 11, 2023Environmental Particulates; Environmental Particulates

  A CUSTOMER 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. 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 17725411 ↗
• MalfunctionSep 6, 2023Device Emits Odor; Environmental Particulates; Device Emits Odor; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR MIST/HAZE AND 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 17694423 ↗
• MalfunctionAug 8, 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 17481772 ↗
• MalfunctionAug 1, 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. 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 17435267 ↗
• MalfunctionJul 31, 2023Environmental Particulates; Environmental Particulates

  WHILE AT CUSTOMER SITE FOR A SEPARATE ISSUE, A FIELD SERVICE ENGINEER REPORTED AN EVENT OF 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 17430714 ↗
• 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. 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 17400058 ↗
• MalfunctionJul 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 17283281 ↗
• MalfunctionJun 20, 2023Device Emits Odor; Device Emits Odor

  WHILE AT CUSTOMER SITE FOR A SEPARATE ISSUE, THE FIELD SERVICE ENGINEER REPORTED AN EVENT OF AN ¿ODOR¿ OR SMELL 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 17167280 ↗
• MalfunctionJun 5, 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. 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 17066054 ↗
• MalfunctionMay 31, 2023Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿HAZE¿ OR VAPOR 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 17035043 ↗
• MalfunctionMay 12, 2023Environmental Particulates; Environmental Particulates

  WHILE AT CUSTOMER SITE FOR A SEPARATE ISSUE, ASP FIELD SERVICE ENGINEER REPORTED AN EVENT OF ¿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 16924629 ↗
• MalfunctionMay 12, 2023Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿MIST¿ OR HAZE EMITTING FROM THE STERRAD® 100NX STERILIZER, AND A HEALTH CARE WORKER (HCW) EXPERIENCED ITCHY EYES AND ITCHY THROAT. THE HCW LEFT THE ROOM AND THE SYMPTOMS RESOLVED WITHIN AN HOUR. NO MEDICAL TREATMENT WAS RECEIVED, AND IT WAS REPORTED THE HCW ¿FEELS FINE AND IS WORKING NORMALLY¿. THE SYMPTOMS RESOLVED WITHOUT MEDICAL INTERVENTION AND WERE ASSESSED TO BE MINOR; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY FOR THE MIST/HAZE ISSUE.

  Patient problems: Eye Irritation; Itching Sensation

  MAUDE report 16924526 ↗
• MalfunctionMay 4, 2023Environmental 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 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 PREVIOUS SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16873397 ↗
• MalfunctionMay 4, 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 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 16873347 ↗
• MalfunctionMay 2, 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 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 16857685 ↗
• MalfunctionApr 28, 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 16832031 ↗
• MalfunctionApr 20, 2023Environmental Particulates; Environmental Particulates

  WHILE AT CUSTOMER SITE, ASP FIELD SERVICE ENGINEER REPORTED AN EVENT OF ¿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 16781893 ↗
• MalfunctionApr 10, 2023Environmental Particulates; Environmental Particulates

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709991 ↗
• MalfunctionApr 4, 2023Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A ¿STRONG 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 16675541 ↗
• MalfunctionMar 20, 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 16576486 ↗
• MalfunctionMar 6, 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 16491663 ↗
• MalfunctionMar 6, 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 16486593 ↗