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STERRAD™ 10104Recalls & reported problems

Advanced Sterilization Products Services Inc. · STERRAD™ 100NX Sterilizer · Class 2

Quick summary

This STERRAD sterilizer is a chemical sterilizer. Reports most often describe particles, haze or an odor coming from the unit, and some describe smoke or leaks, with people nearby reporting eye irritation or headaches. There are 259 reports, with no deaths and 3 injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
259
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 259 adverse event reports that list this exact device (DI 10705037014491), received between Mar 15, 2018 and Apr 8, 2026 — classified as 3 injuries, 256 malfunctions.

The most frequently reported specific device problem is “Environmental Particulates” (133 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Environmental Particulates133
  • Device Emits Odor116
  • Smoking21
  • Fluid/Blood Leak4
  • Gas/Air Leak3
  • Adverse Event Without Identified Device or Use Problem1
  • Appropriate Device Problem Term/Code Not Available1
  • Fogging1

Patient problems

  • No Consequences Or Impact To Patient141
  • No Clinical Signs, Symptoms or Conditions99
  • Headache8
  • No Code Available7
  • Burning Sensation4
  • Insufficient Information4
  • Itching Sensation4
  • Nausea4

Recent adverse event reports

The 25 most recent of 259 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

    ADVANCED STERILIZATION PRODUCTS (ASP) RECEIVED A VOLUNTARY MEDWATCH REPORT FROM THE FDA ON MARCH 12, 2026. IT WAS REPORTED BY A FAMILY MEMBER, A HEALTH CARE WORKER (HCW) IN THE UNITED STATES EXPERIENCED RESPIRATORY SYMPTOMS ON (B)(6) 2026, WHEN HE WAS EXPOSED TO VAPOR/CHEMICAL EMISSIONS WHILE OPERATING OR WORKING NEAR A STERRAD 100NX STERILIZER. IT WAS ALLEGED HE WAS EXPOSED TO FUMES RELEASED FROM THE UNIT OR SURROUNDING AREA, AND SHORTLY AFTER EXPOSURE HE DEVELOPED CHEST TIGHTNESS, COUGHING, SHORTNESS OF BREATH, AND LUNG IRRITATION. IT WAS REPORTED HIS SYMPTOMS PERSISTED AND REQUIRED MEDICAL EVALUATION; HOWEVER, IT WAS NOT REPORTED WHAT TYPE OF MEDICAL TREATMENT WAS RECEIVED. MEDICATIONS WERE LISTED IN THE REPORT AS FOLLOWS: ALBUTEROL, ELIQUIS, PREDNISONE, AND TRELEGY; HOWEVER, IT IS NOT CONFIRMED IF ANY OF THESE WERE GIVEN TO TREAT HIS REPORTED SYMPTOMS AT THE TIME OF THE ALLEGED EVENT OR WERE MEDICATIONS HE TAKES REGULARLY. THE HCW¿S MEDICAL HISTORY IS NOT KNOWN, INCLUDING ANY PRE-EXISTING RESPIRATORY CONDITIONS SUCH AS ASTHMA OR COPD. THE FAMILY MEMBER WHO REPORTED THIS EVENT ASKED TO REMAIN CONFIDENTIAL; THEREFORE, NO FOLLOW-UP CAN BE DONE. LASTLY, IT CANNOT BE CONFIRMED A SER

    Patient problems: Chest Pain; Cough; Dyspnea; Unspecified Respiratory Problem

    MAUDE report 24821202 ↗
  • InjuryOct 15, 2025Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

    IT WAS REPORTED BY A HOSPITAL IN JAPAN TO ASP JAPAN BY MEANS OF THE COMPLAINT PROCESS, THAT AFTER A LOAD WAS STERILIZED, A FEMALE HEALTH CARE WORKER (HCW) PULLED OUT THE TOP SHELF OF A STERRAD 100NX STERILIZER AND IT SLIPPED AND FELL PARTIALLY OUT. IT WAS NOTED SHE ¿PANICKED¿ AND TRIED TO STOP THE SHELF FROM FALLING WITH HER FINGER AND FRACTURED HER MIDDLE FINGER ON HER RIGHT HAND. IT WAS NOTED THE HCW DID NOT GET HER FINGERS STUCK IN BETWEEN THE SHELF RAILS WHEN SHE PANICKED. AFTER CHECKING INSIDE THE CHAMBER, IT WAS NOTED THAT THE UPPER CHAMBER STOP WAS LOOSE ON THE RIGHT SIDE. CLINICAL DETAILS WERE PROVIDED, WHICH REPORTED THE HCW RECEIVED MEDICAL ATTENTION, AND A BONE FRACTURE WAS DIAGNOSED AND CONFIRMED BY X-RAY. A ¿CAST¿ OR SPLINT WAS APPLIED WHICH IS CONSIDERED STANDARD OF CARE. NO MEDICATION WAS GIVEN. THE HCW IS EXPECTED TO MAKE A FULL RECOVERY BY (B)(6) 2025, AND IT WAS REPORTED SHE HAD ALREADY COME BACK TO WORK. THIS COMPLAINT IS DEEMED REPORTABLE AS A SERIOUS INJURY. THE CUSTOMER REPORTED THAT A HCW PANICKED AND FRACTURED HER FINGER WHEN TRYING TO STOP THE SHELF FROM FALLING.

    Patient problems: Bone Fracture(s)

    MAUDE report 23303621 ↗
  • MalfunctionSep 14, 2023Device Emits Odor; Environmental Particulates; Device Emits Odor; Environmental Particulates

    A CUSTOMER REPORTED AN EVENT OF AN ¿ODOR¿ OR SMELL AND A ¿MIST¿ OR HAZE EMITTING FROM THE STERRAD® 100NX STERILIZER, AND THREE HEALTH CARE WORKERS (HCWS) REPORTED EXPERIENCING EYE IRRITATION AND UPSET STOMACH/NAUSEA. THE HCWS RINSED THEIR EYES AT THE EYE-WASH STATION TO RESOLVE THE SYMPTOMS, AND NO REQUIRED TREATMENTS WERE REPORTED RELATED TO THIS EVENT. ADDITIONAL EVENT INFORMATION CONFIRMED HCW1 DID NOT REQUIRE MEDICAL TREATMENT, AND HCW1 HEALTH STATUS WAS REPORTED AS ¿OK." IT WAS FURTHER NOTED THAT ALL THREE HCWS CONTINUE TO WORK IN THE DEPARTMENT. THE CUSTOMER ADDITIONALLY REPORTED THAT A THIRD-PARTY SERVICER (ARJO) RECENTLY REPLACED A PUMP, AND STATED THAT THE PUMP MIGHT NOT BE A GENUINE ASP PART. IT WAS FURTHER REPORTED THE TECHNICIAN REPLACED THE PUMP AGAIN, BUT THE ODOR/SMELLS ISSUE PERSISTED. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THERE WERE NO MEDICAL TREATMENTS REPORTED ASSOCIATED WITH THIS EVENT, AND THE REPORTED SYMPTOMS WERE ASSESSED TO BE MINOR INJURIES. HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY RELATED TO ODOR/SMELLS AND MIST/HAZE ISSUES.

    Patient problems: Eye Irritation; Nausea; Red Eye(s)

    MAUDE report 17749830 ↗
  • MalfunctionSep 8, 2023Device Emits Odor; Environmental Particulates; Device Emits Odor; Environmental Particulates

    A CUSTOMER REPORTED AN EVENT OF A ¿MIST¿ OR HAZE AND A ¿BURNING 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 17715299 ↗
  • MalfunctionAug 30, 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 17655464 ↗
  • MalfunctionAug 24, 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 17612746 ↗
  • MalfunctionAug 17, 2023Environmental Particulates; Environmental Particulates

    WHILE AT CUSTOMER SITE FOR A PREVENTIVE MAINTENANCE, THE 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. 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 17569503 ↗
  • MalfunctionAug 17, 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 17565430 ↗
  • MalfunctionAug 14, 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 17546922 ↗
  • MalfunctionAug 14, 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 17546670 ↗
  • MalfunctionJul 26, 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 17401190 ↗
  • MalfunctionJul 26, 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 17400747 ↗
  • MalfunctionJul 20, 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 17362625 ↗
  • MalfunctionJul 17, 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 17333274 ↗
  • MalfunctionJul 12, 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 17313047 ↗
  • MalfunctionJun 29, 2023Device Emits Odor; Environmental Particulates; Device Emits Odor; Environmental Particulates

    A CUSTOMER REPORTED AN EVENT OF A ¿SMELL¿ OR ODOR, AND ¿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 17233940 ↗
  • 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 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 17152693 ↗
  • MalfunctionJun 14, 2023Environmental Particulates; Environmental Particulates

    A CUSTOMER REPORTED AN EVENT OF A ¿FOG¿ OR MIST/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 PREVIOUS SERIOUS INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17132069 ↗
  • MalfunctionMay 26, 2023Environmental Particulates; Environmental Particulates

    A CUSTOMER REPORTED AN EVENT OF A ¿WHITE 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 17010947 ↗
  • MalfunctionMay 1, 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 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 16850253 ↗
  • MalfunctionMar 16, 2023Environmental Particulates; Environmental Particulates

    A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR MIST EMITTING FROM THE STERRAD® 100NX STERILIZER. THE CUSTOMER STATED THEY POWERED OFF THE UNIT AND DISCONTINUED USE. 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 16556579 ↗
  • MalfunctionMar 15, 2023Environmental 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 PREVIOUS SERIOUS INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16550728 ↗
  • MalfunctionMar 6, 2023Environmental Particulates; Environmental Particulates

    A CUSTOMER REPORTED AN EVENT OF A ¿HAZE¿ 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 16488921 ↗
  • MalfunctionFeb 24, 2023Device Emits Odor; Device Emits Odor

    A CUSTOMER REPORTED AN EVENT OF A ¿STRONG 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 16436584 ↗
  • MalfunctionFeb 2, 2023Environmental 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. 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 16287804 ↗

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.

Other Sterilizer, chemical devices

All Sterilizer, chemical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.