InstaClear Lens Cleaner-indicated for use during routine diagnostic… — Class II medical device recall Z-1368-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2024-04-03. Japanese IFU version had slightly different language and illustrations from the English IFU, which could contr
| Recall number | Z-1368-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2024-01-16 |
| Classified | 2024-03-22 |
| Reported by FDA | 2024-04-03 |
| Countries outside the US | JP |
| Quantity | 102,279 units |
| Model numbers | LCS1500UNOL, LCS1530BTOL, LCS1530TPOL, LCS1545BTOL, LCS1545TPOL, LCS1570BTOL, LCS1570TPOL, LCS1800UNST, LCS1830BTST, LCS1830TPST, LCS1845BTST, LCS1845TPST, LCS1870BTST, LCS1870TPST, LCS4K00UNOL, LCS4K30BTOL, LCS4K30TPOL, LCS4K45BTOL, LCS4K45TPOL, LCS4K70BTOL, LCS4K70TPOL |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1368-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.