Z-1888-2024 Class II Ongoing
FDA device recall Z-1888-2024 was initiated by Olympus Corporation Of The Americas on Apr 3, 2024 and is designated Class II. Reason for recall: Potential for distal end of the sheath to break off during a procedure. The recall status is ongoing. Affected quantity: pending.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2024
- Initiation Date
- Apr 3, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- pending
Product Description
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 for Recall
Potential for distal end of the sheath to break off during a procedure.
Distribution Pattern
Domestic: Nationwide Distribution; Foreign: Australia, Canada, Germany, Japan.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1888-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026