Reliance Endoscope Processing System (REPS), STERIS… recallZ-2263-2013 · Steris Corporation · initiated Aug 29, 2013
Class II Terminated All recalls posted in September 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Steris Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Use error
What the company is doing
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.
Recall details
- Recall number
- Z-2263-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 29, 2013
- Posted by the FDA
- Sep 20, 2013
- Recalling firm
- Steris Corporation
- Quantity
- 266 units
- Product code
- NZA
- FDA submissions
- K040049, K102244, K110453
- 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 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.
Code information (models, lots, serial numbers)
Model #'s: MB30001, MB30002, MB30003, MB000077, MB000078, MB000079, MB000080 and MB000081. Serial number range 3625606001 - 3608912002
Other devices under the same FDA submission
1 device cleared under K040049, K102244, K110453 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Reliance EPSCorporation Steris Canada · Accessories, germicide, cleaning, for endoscopes1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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