Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1264-2022 — Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R

U.S. FDA — Device Enforcement · United States · 2022-04-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1264-2022
Date of alert
2022-04-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Olympus Corporation of the Americas
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04953170340833
Reported risk: Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.