Z-2263-2013Class II

Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA...

Name: Z-2263-2013 Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA...
Creator: Steris Corporation
Published: 2013-08-29
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2013-08-29 / Terminated

FDA source

Steris Corporation began a recall of Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is... on 2013-08-29. FDA classified it as Class II and gives the reason as "The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed FUJINON G5 & G8 type flexible GI endoscopes does not connect to the main air/water channel within the light...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2263-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-29
Posted: 2013-09-20
Terminated: 2014-07-03
Recalling firm: STERIS Corporation
Product: Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical devices.
Product code: NZA Accessories, Germicide, Cleaning, For Endoscopes
Reason for recall: The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed FUJINON G5 & G8 type flexible GI endoscopes does not connect to the main air/water channel within the light guide (LG) connection head and, as a result, the air pipe does not receive forced flow during the Reliance EPS processing cycle.
FDA root cause: Use error
Action: Steris sent an "URGENT PRODUCT SAFETY NOTICE" dated September 5, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in commerce: 266 units
Distribution: Worldwide Distribution-USA (nationwide) including the states of AK, CO, FL, GA, HI, ID, IL, KS, LA, MD, MN, MO, MT, NE, NM, OH, PA, SC, UT, & WY and the countries of Australia, Canada & Spain.
Product codes and lots: Model #'s: MB30001, MB30002, MB30003, MB000077, MB000078, MB000079, MB000080 and MB000081. Serial number range 3625606001 - 3608912002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2263-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2263-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-02	2013-09-20

Product code NZA

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)