STERRAD™ 10113Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705037014583), received between Sep 11, 2018 and Feb 11, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Expiration Date Error” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2020Expiration Date Error; Expiration Date Error

  A CUSTOMER REPORTED AN EXPIRED CASSETTE WAS USED WITH THEIR STERRAD® 100S STERILIZER AND THREE CYCLES WERE RUN AND RELEASED FOR USE. THE STERRAD® 100S STERILIZER HAD NOT BEEN IN USE SINCE (B)(6) 2019. ON (B)(6) 24, 2020, THE STERRAD® 100S WAS POWERED BACK ON DUE TO ANOTHER STERILIZER THAT WAS NOT OPERATING. THE CUSTOMER STATED THAT AFTER THE LAST OF THE THREE CYCLES WERE RUN AND WHILE REMOVING THE CASSETTE FROM THE STERILIZER, THE CUSTOMER NOTICED THE USE BY DATE ON THE CASSETTE WAS (B)(6) 2019 AND WAS EXPIRED. THE CASSETTE HAD BEEN SITTING IN THE STERRAD SINCE OCTOBER WHEN IT WAS LAST USED AND DID NOT EJECT FROM THE STERRAD PRIOR TO USE. ALL ITEMS IN THE LOADS WERE THEN RECALLED AND REPROCESSED EXCEPT TWO ITEMS, A RIGID TELESCOPE AND A CAMERA AND LIGHT LEAD WHICH HAD BEEN RELEASED AND USED ON PATIENTS. THE CUSTOMER STATED THEY HAD USED A BIOLOGICAL WITH THE RELEASED LOAD AND THE BIOLOGICAL TEST RESULT WAS NEGATIVE AND PASSED. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9696121 ↗
• MalfunctionSep 11, 2018Expiration Date Error; Expiration Date Error

  A CUSTOMER REPORTED USING AN EXPIRED STERRAD® 100S CASSETTE IN A STERRAD® 100S STERILIZER AND THE LOAD WAS RELEASED FOR USE ON PATIENT(S). THEY STATED THE STERRAD® DID NOT REJECT THE CASSETTE AND THE CYCLE COMPLETED. THE CUSTOMER NOTICED THE ERROR WHEN REVIEWING THE PRINTOUT ON (B)(6) 2018 FOR A CYCLE CANCELLATION OF ANOTHER ISSUE. WHEN THE CUSTOMER NOTICED THE ERROR, THEY IMMEDIATELY REMOVED AND DISCARDED THE CASSETTE. THERE IS NO REPORT OF ANY INFECTION OR INJURY AS A RESULT OF THIS ISSUE. AS A MATTER OF POLICY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DECIDED TO REPORT CASES WHERE A CUSTOMER REPORTS USING EXPIRED AN STERRAD® 100S CASSETTE AND THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) SINCE STERILIZATION CANNOT BE GUARANTEED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7865550 ↗

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-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-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-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-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-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-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-1629-2008 · Feb 25, 2008 · Terminated
  STERRAD 50 Sterilization System, Product Code 10050 Used to sterilize heat and moisture sensitive reusable medical devices.
• 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-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