STERRAD™ 10104-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705037048687), received between Aug 30, 2018 and Sep 28, 2023 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Environmental Particulates” (10 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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2023Device Handling Problem; Device Handling Problem

  A CUSTOMER REPORTED A FEMALE HEALTH CARE WORKER (HCW) SUFFERED AN INJURY TO THE RIGHT RING FINGER WHILE REMOVING A NON-ASP TRAY/BOX (MANUFACTURER UNKNOWN) FROM THE STERRAD® 100NX STERILIZER AFTER A COMPLETED STANDARD CYCLE. THE CUSTOMER STATED THAT ONLY THE TOP SHELF OF THE STERILIZER WAS USED, AND THE TRAY/BOX WITH THE LOAD CONTENTS WEIGHED A TOTAL OF 10 KG (WEIGHT LIMIT EXCEEDED AS PER THE STERRAD® 100NX USER'S GUIDE). THE CUSTOMER REPORTED THAT THE TOP SHELF DID NOT FALL, BUT THE SHELF ¿DERAILED,¿ AND THE NON-ASP TRAY/BOX FELL AND ¿DISLOCATED¿ THE HCW¿S FINGER BACKWARDS, RESULTING IN IMMEDIATE PAIN AND SWELLING. THE CUSTOMER CONFIRMED THAT ONLY THE NON-ASP TRAY/BOX MADE CONTACT WITH THE INJURED AREA. THE HCW WAS SEEN BY AN ORTHOPEDIC HAND SPECIALIST ON (B)(6) 2023 AND REPORTED THAT THE SYMPTOMS PERSISTED ON (B)(6) 2023, NOTING ¿THE CASE IS SURGICAL.¿ THE CUSTOMER REPORTED THAT NO MEDICAL DOCUMENTATION WAS AVAILABLE BUT STATED THAT THE DOCTOR REPORTED THE HCW HAD A TORN LIGAMENT (GRADE UNKNOWN) ON THE RING FINGER. AT THE TIME OF THIS REPORT, IT IS UNKNOWN IF MEDICAL OR SURGICAL INTERVENTION HAS BEEN PERFORMED, HOWEVER, IT WAS NOTED THE HCW IS ¿RECOVERING WELL¿ AND UNDER OBSERVATI

  Patient problems: Damage to Ligament(s); Pain; Swelling/ Edema

  MAUDE report 17840053 ↗
• MalfunctionSep 7, 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. 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 17706339 ↗
• MalfunctionJun 19, 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 BIOMED WAS PROVIDED REMOTE SUPPORT FOR UNIT ASSESSMENT. 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 17152869 ↗
• MalfunctionFeb 24, 2023Environmental Particulates; Environmental Particulates

  WHILE ON SITE FOR A SEPARATE ISSUE, A FIELD SERVICE ENGINEER OBSERVED A ¿SMOKE¿ 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 16439997 ↗
• MalfunctionDec 27, 2022Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A ¿STRONG ODOR¿ OR SMELL EMITTING FROM THE STERRAD® 100NX STERILIZER, AND HEALTH CARE WORKERS (HCWS) REPORTED EXPERIENCING RESPIRATORY AND SKIN REACTIONS THAT THEY ATTRIBUTED TO ¿PEROXIDE¿ WHEN HANDLING THE LOAD AT THE END OF THE STERILIZATION CYCLE. THE SYMPTOMS WERE DESCRIBED AS ITCHING AND ¿BURNING¿ ON ARMS AND FACE, REDDENED EYEBROWS, AND IRRITATION IN THE THROAT AND DRY MOUTH WITH A ¿BURNING¿ SENSATION. THE CUSTOMER STATED THAT THE HCWS WERE INSTRUCTED TO LEAVE THE ROOM WHEN NOT IN USE. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THE CUSTOMER DID NOT SPECIFY HOW MANY HCWS WERE AFFECTED, AND NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED. BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THIS REPORT, THE HCWS SYMPTOMS WERE ASSESSED AS MINOR INJURIES; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY FOR ODOR/SMELLS ISSUE.

  Patient problems: Eye Burn; Itching Sensation; Skin Burning Sensation; Unspecified Respiratory Problem

  MAUDE report 16057398 ↗
• MalfunctionNov 22, 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 15846463 ↗
• MalfunctionSep 6, 2022Environmental Particulates; Environmental Particulates

  A DISTRIBUTOR REPORTED AN EVENT OF 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 15366080 ↗
• MalfunctionAug 10, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE CLOUD¿ 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 15201190 ↗
• MalfunctionMay 21, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE CLOUD¿ 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 14465840 ↗
• MalfunctionDec 14, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003966 ↗
• MalfunctionJul 1, 2020Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A "STRONG BURNING SMELL" (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 Consequences Or Impact To Patient

  MAUDE report 10222362 ↗
• 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 8219975 ↗
• MalfunctionNov 28, 2018Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A "SMELL OF PEROXIDE" OR ODOR AT THE END OF THE CYCLE 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 8113244 ↗
• MalfunctionAug 30, 2018Environmental 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 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 7832733 ↗