Reliance Endoscope Processing System — Class II medical device recall Z-2263-2013
Terminated recall by Steris Corporation, reported 2013-10-02, distributed nationwide. The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed
| Recall number | Z-2263-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2013-08-29 |
| Classified | 2013-09-20 |
| Reported by FDA | 2013-10-02 |
| Terminated | 2014-07-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, ES |
| Quantity | 266 units |
| Model numbers | MB000077, MB000078, MB000079, MB000080, MB000081, MB30001, MB30002, MB30003 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2263-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.