Steris Corporation: Medical Device Recall in 2013 - (Recall #: Z-2263-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: August 29, 2013

Date Posted: October 2, 2013

Recall Number: Z-2263-2013

Event ID: 66247

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.

Status: Terminated

Product Quantity: 266 units

Code Information:

Model #'s: MB30001, MB30002, MB30003, MB000077, MB000078, MB000079, MB000080 and MB000081. Serial number range 3625606001 - 3608912002

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated