Olympus Corporation of the Americas: Medical Device Recall in 2024 - (Recall #: Z-1368-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LCS1830BTST LCS4K30BTOL LCS1530TPOL LCS1830TPST LCS4K30TPOL LCS1545BTOL LCS1845BTST LCS4K45BTOL LCS1545TPOL LCS1845TPST LCS4K45TPOL LCS1570BTOL LCS1870BTST LCS4K70BTOL LCS1570TPOL LCS1870TPST LCS4K70TPOL

Product Classification:

Class II

Date Initiated: January 16, 2024

Date Posted: April 3, 2024

Recall Number: Z-1368-2024

Event ID: 94067

Reason for Recall:

Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency globally, the Japanese IFU will be updated to reflect the instructions in the English IFU

Status: Ongoing

Product Quantity: 102,279 units (OUS Only)

Code Information:

UDI-DI: N/A All Lot Numbers

Distribution Pattern:

International distribution to the country of Japan.

Voluntary or Mandated:

Voluntary: Firm initiated