STERRAD™ 10104-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705037047598), received between May 7, 2019 and Mar 8, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Emits Odor” (2 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 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. 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 16504620 ↗
• MalfunctionMar 16, 2020Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A "STRONG CHEMICAL 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 9836758 ↗
• MalfunctionMay 7, 2019Device Emits Odor; Device Emits Odor

  A CUSTOMER REPORTED AN EVENT OF A "HYDROGEN PEROXIDE ODOR" OR SMELL EMITTING FROM THE STERRAD® 100NX STERILIZER. THE CUSTOMER ALSO STATED THAT THE CHEMICAL INDICATOR ALARM IN THE ROOM ACTIVATED WHILE A CYCLE WAS IN PROGRESS. 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 8586850 ↗

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.