Z-1368-2024 Class II Ongoing
FDA device recall Z-1368-2024 was initiated by Olympus Corporation Of The Americas on Jan 16, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 102,279 units (OUS Only).
Recall Details
- Product Type
- Devices
- Report Date
- Apr 3, 2024
- Initiation Date
- Jan 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 102,279 units (OUS Only)
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
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 Pattern
International distribution to the country of Japan.
Code Information
UDI-DI: N/A All Lot Numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1368-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026