Sterrad 10101Recalls & reported problems

Summary

The FDA's MAUDE database contains 258 adverse event reports that list this exact device (DI 10705037014460), received between Mar 15, 2018 and Jun 24, 2026 — classified as 5 injuries, 253 malfunctions.

The most frequently reported specific device problem is “Environmental Particulates” (178 reports).

13 other recalls cover devices cleared under the same FDA submission (K023290, K991999); 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 258 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Environmental Particulates

  IT WAS REPORTED FROM A HOSPITAL IN (B)(6), A FEMALE HEALTH CARE WORKER (HCW) WITH A HISTORY OF ASTHMA EXPERIENCED A RESPIRATORY REACTION AND SOUGHT EMERGENCY CARE RELATED TO OIL MIST FROM A STERRAD 100S STERILIZER. REGARDING THIS EVENT, PREVIOUS CYCLES WERE RUN, THEN A SHORT CYCLE STARTED AND THE HCW LEFT THE ROOM, AND THE DOOR WAS CLOSED. UPON RETURN IT WAS NOTED THAT OIL MIST HAD FILLED THE ROOM. CLINICAL DETAILS WERE PROVIDED BY THE OCCUPATIONAL HEALTH PHYSICIAN, WHO REPORTED THE HCW EXPERIENCED SHORTNESS OF BREATH AND WAS EVALUATED IN THE EMERGENCY DEPARTMENT WHERE SHE RECEIVED THE FOLLOWING TREATMENT: SUBCUTANEOUS ADRENALINE, OXYGEN VIA NASAL CANNULA, IV MEDICATION AND INHALATION THERAPY (SPECIFIC NAMES OF MEDICATION NOT KNOWN). LASTLY, IT WAS REPORTED SHE IS WELL, WITH NO COMPLICATIONS, AND SHE CONTINUES TO WORK IN THE DEPARTMENT WITH THE STERRAD UNIT. REGARDING THE ROOM WHERE THE STERILIZER IS LOCATED, IT WAS REPORTED THAT IT IS SMALL, AND ISOLATED WHEN THE DOOR IS CLOSED AND NOT WELL VENTILATED. THERE ARE NO WINDOWS, ONLY AIR CONDITIONING. AIR EXCHANGES HAVE NOT BEEN MEASURED. THIS COMPLAINT IS DEEMED REPORTABLE AS A SERIOUS INJURY. THE HCW RECEIVED MEDICATION TO TREAT HER

  Patient problems: Dyspnea

  MAUDE report 25616029 ↗
• MalfunctionSep 22, 2023Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR MIST/HAZE EMITTING FROM ¿THE FILTER OF THE VACUUM PUMP¿ OF THE STERRAD® 100S STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE CUSTOMER WAS INSTRUCTED TO POWER OFF THE UNIT AND DISCONTINUE USE. 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 17803960 ↗
• MalfunctionAug 29, 2023Device Emits Odor; Device Emits Odor

  WHILE AT CUSTOMER SITE FOR A SEPARATE ISSUE, THE FIELD SERVICE ENGINEER REPORTED AN EVENT OF AN ¿OILY SMELL¿ OR ODOR EMITTING FROM THE STERRAD® 100S 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 17642630 ↗
• MalfunctionJul 18, 2023Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A ¿SMELL¿ OR ODOR EMITTING FROM THE STERRAD® 100S 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 17342487 ↗
• MalfunctionJul 11, 2023Device Emits Odor; Environmental Particulates; Device Emits Odor; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR MIST/HAZE AND A ¿SMELL¿ OR ODOR EMITTING FROM THE STERRAD® 100S STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. A FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ON SITE. 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 17301072 ↗
• MalfunctionJun 30, 2023Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A ¿SMELL¿ OR ODOR EMITTING FROM THE STERRAD® 100S 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 17243671 ↗
• MalfunctionJun 14, 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® 100S 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 17132063 ↗
• MalfunctionJun 14, 2023Device Emits Odor; Device Emits Odor

  WHILE AT CUSTOMER SITE FOR A SEPARATE ISSUE, THE FIELD SERVICE ENGINEER REPORTED AN EVENT OF A ¿SMELL¿ OR ODOR EMITTING FROM THE STERRAD® 100S 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 17132019 ↗
• MalfunctionJun 13, 2023Environmental Particulates; Environmental Particulates

  WHILE AT CUSTOMER SITE FOR A SEPARATE ISSUE, THE FIELD SERVICE ENGINEER REPORTED AN EVENT OF AN ¿OIL SPRAY¿ OR MIST/VAPOR EMITTING FROM THE STERRAD® 100S 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 17121911 ↗
• MalfunctionMay 30, 2023Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿HAZE¿ OR MIST EMITTING FROM THE STERRAD® 100S 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 17028075 ↗
• MalfunctionMay 12, 2023Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF ¿SMOKE¿ OR MIST/HAZE EMITTING FROM THE STERRAD® 100S 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 16924445 ↗
• MalfunctionMay 4, 2023Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF ¿SMOKE¿ OR MIST/HAZE EMITTING FROM THE STERRAD® 100S 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 16873342 ↗
• MalfunctionApr 21, 2023Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR MIST/HAZE EMITTING FROM THE STERRAD® 100S 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 16792239 ↗
• MalfunctionApr 20, 2023Device Emits Odor; Device Emits Odor

  WHILE AT CUSTOMER SITE FOR A SEPARATE ISSUE, ASP FIELD SERVICE ENGINEER REPORTED AN EVENT OF A ¿SMELL¿ OR ODOR EMITTING FROM THE STERRAD® 100S 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 16781940 ↗
• MalfunctionApr 5, 2023Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF AN ¿OIL SMELL¿ OR ODOR EMITTING FROM THE STERRAD® 100S 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 16685814 ↗
• MalfunctionMar 16, 2023Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿WHITE SMOKE¿ OR MIST EMITTING FROM THE STERRAD® 100S STERILIZER. THE CUSTOMER POWERED OFF THE UNIT AND DISCONTINUED USE. 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 16556612 ↗
• MalfunctionFeb 23, 2023Device Emits Odor; Environmental Particulates; Device Emits Odor; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF AN ODOR/SMELL AND MIST/HAZE EMITTING FROM THE STERRAD® 100S 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 16432719 ↗
• MalfunctionFeb 14, 2023Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF ¿FUMES¿ OR SMOKE/HAZE EMITTING FROM THE STERRAD® 100S 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 16372703 ↗
• MalfunctionFeb 13, 2023Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR HAZE EMITTING FROM THE STERRAD® 100S STERILIZER THAT OCCURRED ON (B)(6) 2022. THE CUSTOMER STATED THAT THEY POWERED OFF THE UNIT AND PLANNED TO REPLACE THE SUSPECT UNIT WITH A NEW 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 16364519 ↗
• MalfunctionFeb 1, 2023Device Emits Odor; Environmental Particulates; Device Emits Odor; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿STRONG SMELL¿ OR ODOR EMITTING FROM THE STERRAD® 100S STERILIZER. THE CUSTOMER¿S CLINICAL ENGINEER/FACILITY BIOMED IDENTIFIED AN ADDITIONAL ISSUE OF MIST/HAZE DURING UNIT ASSESSMENT, AND THEY REPLACED THE CATALYTIC CONVERTER TO RESOLVE THE ISSUES. THE CUSTOMER CONFIRMED THE UNIT WAS RESTORED TO PROPER FUNCTION. 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 16278623 ↗
• MalfunctionNov 28, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿HAZE¿ OR MIST EMITTING FROM THE STERRAD® 100S 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 15874720 ↗
• MalfunctionNov 19, 2022Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A ¿SMELL¿ OR ODOR EMITTING FROM THE STERRAD® 100S 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 15830300 ↗
• MalfunctionNov 4, 2022Environmental Particulates; Environmental Particulates

  A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR HAZE EMITTING FROM THE STERRAD® 100S 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 15729021 ↗
• MalfunctionOct 6, 2022Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A ¿SMELL¿ OR ODOR EMITTING FROM THE STERRAD® 100S 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 15556064 ↗
• MalfunctionSep 15, 2022Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A ¿BAD SMELL¿ OR ODOR EMITTING FROM THE STERRAD® 100S 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 15428813 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023290, K991999. One submission often covers many models, so check the product and lot details in each record.

• Z-0843-2015 · Nov 4, 2014 · Terminated
  STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and m
• Z-0842-2015 · Nov 4, 2014 · Terminated
  STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moi
• Z-0746-2014 · Dec 16, 2013 · Terminated
  STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to
• Z-0745-2014 · Dec 16, 2013 · Terminated
  STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inact
• Z-0744-2014 · Dec 16, 2013 · Terminated
  STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inac
• Z-2337-2012 · Jun 19, 2012 · Terminated
  STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture s
• Z-1419-2009 · Mar 9, 2009 · Terminated
  STERRAD 50 Sterilization System Product Code 10050 The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive r
• Z-0340-2009 · Oct 17, 2008 · Terminated
  STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and hardware components. The STERRAD Sterilization System is a low-temperature, general purpose s
• Z-1628-2008 · Feb 25, 2008 · Terminated
  STERRAD 100S Sterilization System, Product Code 10101 Used to sterilize heat and moisture sensitive reusable medical devices.
• Z-1629-2008 · Feb 25, 2008 · Terminated
  STERRAD 50 Sterilization System, Product Code 10050 Used to sterilize heat and moisture sensitive reusable medical devices.
• Z-0844-2008 · Nov 12, 2007 · Terminated
  STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers, Document Numbers 15-53229 & 15-53230; STERRAD NX Sterilizers Compatible Medi
• Z-0845-2008 · Nov 12, 2007 · Terminated
  STERRAD 100S Sterilizer, Product Code: 10101, Advanced Sterilization Products, Irvine, CA
• Z-0197-06 · Sep 16, 2005 · Terminated
  Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S