Recall Z-1888-2024— Olympus Corporation of the Americas

Name: FDA recall Z-1888-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-03

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2024-04-03. It names one FDA 510(k) clearance: K152531. Product: InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.. Reason: Potential for distal end of the sheath to break off during a procedure..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2024-04-03
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K152531 — InstaClear Lens CleanerGyrus Acmi, Inc.·cleared 2016-01-15

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

InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.

Reason for recall

Potential for distal end of the sheath to break off during a procedure.

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