# FDA recall Z-1368-2024

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2024-01-16.

## Product

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

## 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

## Distribution

International distribution to the country of Japan.

## Key facts

- **Recall number:** Z-1368-2024
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-16
- **Report date:** 2024-04-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1368-2024

## Citation

> AI Analytics. FDA recall Z-1368-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1368-2024. Source: US FDA. Licensed CC0.

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