FDA Device recall Z-1888-2024
InstaClear Lens Sheath
- FDA Device
- Class II
- ongoing
- Published 2024-05-29
On 2024-05-29 the FDA classified a Class II recall of InstaClear Lens Sheath by Olympus, citing potential for distal end of the sheath to break off during a procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1888-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-03 |
| Published | 2024-05-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
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.
Identifiers
| code_info | Model No. LCS4K30BTOL, LCS1530TPOL, LCS1830TPST, LCS4K30TPOL, LCS1545BTOL, LCS1845BTST, LCS4K45BTOL, LCS1545TPOL, LCS18…Model No. LCS4K30BTOL, LCS1530TPOL, LCS1830TPST, LCS4K30TPOL, LCS1545BTOL, LCS1845BTST, LCS4K45BTOL, LCS1545TPOL, LCS1845TPST, LCS4K45TPOL, LCS1570BTOL, LCS1870BTST, LCS4K70BTOL, LCS1570TPOL, LCS1870TPST, LCS4K70TPOL; UDI-DI: 00821925040137, 00821925040151, 00821925040144, 00821925040175, 00821925040168, 00821925040199, 00821925040182, 00821925040083, 00821925040076, 00821925040106, 00821925040090, 00821925040120, 00821925040113, 00821925040069; All Lot Numbers. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1888-2024%22
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