Z-0616-2014Class II

SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The...

Name: Z-0616-2014 SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The...
Creator: Steris Corporation
Published: 2013-11-21
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2013-11-21 / Terminated / root cause: design

FDA source

Steris Corporation began a recall of SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System... on 2013-11-21. FDA classified it as Class II and gives the reason as "Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0616-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-21
Posted: 2013-12-31
Terminated: 2014-06-16
Recalling firm: STERIS Corporation
Product: SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
Product code: MLR Sterilizer, Chemical
Reason for recall: Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts.
Root cause tag: design
FDA root cause: Device Design
Action: STERIS sent an Urgent Voluntary Field Correction Notice dated November 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that a STERIS Field Service Representative would contact their facility to schedule installation of the new hardware and updated software on their SYSTEM IE Liquid Chemical Sterilant Processing System(s). Customers were instructed that they may continue to operate the SYSTEM IE processor prior to the completion of the update. Customers with questions were instructed to contact STERIS Field Service Dispatch at 1-800-333-8828. For questions regarding this recall call 440-392-7519.
Quantity in commerce: 6,028 units
Distribution: Nationwide Distribution - USA (nationwide) and the District of Columbia and Puerto Rico. Product was also shipped to the following countries: Afghanistan, Bahrain, Hong Kong, Italy, Saudi Arabia, Turkey & United Kingdom.
Product codes and lots: Model #6500 & 7500

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0616-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0616-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-31

Product code MLR

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)