Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The inte...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2263-2013.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2263-2013.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2263-2013.
Steris Corporation
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Steris Corporation Recall FAQ
Steris Corporation is the subject of a medical devices safety report: Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The inte.... The notice was published on August 29, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 266 units are potentially affected.