Z-0746-2014Class II

STERRAD 100S Sterilization System

Name: Z-0746-2014 STERRAD 100S Sterilization System
Creator: Advanced Sterilization Products
Published: 2013-12-16
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2013-12-16 / Terminated / root cause: sterility

FDA source

Advanced Sterilization Products began a recall of STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the... on 2013-12-16. FDA classified it as Class II and gives the reason as "Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0746-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-16
Posted: 2014-01-14
Terminated: 2014-03-27
Recalling firm: Advanced Sterilization Products
Product: 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 inactivate microorganisms on a broad range of medical devices and surgical instruments.
Product code: FLF Sterilizer, Ethylene-Oxide Gas
Reason for recall: Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Advanced Sterilization Products (ASP) sent an Urgent Medical Device Field Safety Notification dated December 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the customer response forms. Customers with questions were also instructed to contact ASP Professional Services directly at (888) 783-7723 and select option number 2. For questions regarding this recall call 949-453-6400.
Quantity in commerce: 2366 units
Distribution: Nationwide Distribution
Product codes and lots: not available

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0746-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0744-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0745-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0746-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14

Product code FLF

K023290Class IISterrad 50 & Sterrad 100S SterilizersAdvanced Sterilization Products / cleared 2003-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)