Z-2036-2014Class III

Reliance 1227 Cart and Utensil Washer/Disinfector

Name: Z-2036-2014 Reliance 1227 Cart and Utensil Washer/Disinfector
Creator: Steris Corporation
Published: 2014-06-30
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2014-06-30 / Terminated / root cause: design

FDA source

Steris Corporation began a recall of Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the... on 2014-06-30. FDA classified it as Class III and gives the reason as "STERIS has identified that deformation of the washers door handle pin may occur when the door handle is rotated with sufficient force. Should deformation and/or breakage of the door handle pin occur there is a potential...". 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-2036-2014
Classification: Class III
Status: Terminated
Initiated: 2014-06-30
Posted: 2014-07-10
Terminated: 2015-07-01
Recalling firm: STERIS Corporation
Product: Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theater shoes and other miscellaneous reusable items used in the care of patients.
Product code: MEC Disinfector, Medical Devices
Reason for recall: STERIS has identified that deformation of the washers door handle pin may occur when the door handle is rotated with sufficient force. Should deformation and/or breakage of the door handle pin occur there is a potential for the washer door to become inoperable.
Root cause tag: design
FDA root cause: Device Design
Action: Customers will be notified via onsite visits by STERIS Field Service Technicians to each affected Customer site. These visits will be documented and monitored until completion.
Quantity in commerce: 37
Distribution: US Nationwide Distribution - in the states of AL, AR, CA, DE, FL, GA, IL, IA, LA, MA, MI, NJ, NY, OH, OK, OR, SC, TX, VA. and in the country of Canada.
Product codes and lots: Serial Number Range: 3632511020 - 3613214010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2036-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2036-2014	Class III	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-10

Product code MEC

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)