Z-2335-2012Class II

The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is...

Name: Z-2335-2012 The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is...
Creator: Steris Corporation
Published: 2012-08-01
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2012-08-01 / Terminated / root cause: manufacturing process

FDA source

Steris Corporation began a recall of The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of... on 2012-08-01. FDA classified it as Class II and gives the reason as "The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2335-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-01
Posted: 2012-09-07
Terminated: 2014-06-06
Recalling firm: STERIS Corporation
Product: The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid 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: MED Sterilant, Medical Devices
Reason for recall: The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: STERIS sent a Urgent Voluntary Field Correction Notice letter dated August 1, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. STERIS has received no reports of injuries associated with the disconnection of a SYSTEM IE water hose. STERIS Corporation will instill new hoses and connections on your SYSTEM IE Liquid Chemical Sterilant Processing System. For further information or if you have any questions regarding our visit to your facility, please contact STERIS Field Service Dispatch at 1-800-333-8828.
Quantity in commerce: 6,051 units
Distribution: Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong.
Product codes and lots: Model #: P6500, S/N 400000 through 406294

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2335-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2335-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-07

Product code MED

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)