Recall Z-1264-2022— Olympus Corporation of the Americas

Name: FDA recall Z-1264-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-20

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2022-04-20. It names one FDA 510(k) clearance: K172298. Product: Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R. Reason: 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..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2022-04-20
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K172298 — OLYMPUS URF-P6/P6ROlympus Medical Systems Corp.·cleared 2018-03-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.