Olympus InstaClear Lens Sheath Recalled for Potential Distal End Breakage
Olympus has recalled InstaClear Lens Sheaths used in rigid endoscopy because the distal end may break off during procedures. All lot numbers of multiple model variants distributed in the U.S. and internationally are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with potential for breakage during use. No illnesses or injuries have been reported—only theoretical risk. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, placing it at High severity.
Plain-English summary
Olympus Corporation of the Americas is recalling InstaClear Lens Sheaths, which are used to clean and clear the lens of rigid endoscopes during nasal surgical procedures without requiring removal from the nasal cavity.
The sheaths are being recalled because of the potential for the distal end to break off during a procedure. The recall affects all lot numbers of multiple model numbers including LCS4K30BTOL, LCS1530TPOL, LCS1830TPST, LCS4K30TPOL, LCS1545BTOL, LCS1845BTST, LCS4K45BTOL, LCS1545TPOL, LCS1845TPST, LCS4K45TPOL, LCS1570BTOL, LCS1870BTST, LCS4K70BTOL, LCS1570TPOL, and LCS1870TPST. These devices have been distributed domestically throughout the United States and internationally to Australia, Canada, Germany, and Japan.
The recalled product
- 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.
- Manufacturer
- Olympus Corporation of the Americas
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No. LCS4K30BTOL
- LCS1530TPOL
- LCS1830TPST
- LCS4K30TPOL
- LCS1545BTOL
- LCS1845BTST
- LCS4K45BTOL
- LCS1545TPOL
- LCS1845TPST
- LCS4K45TPOL
- LCS1570BTOL
- LCS1870BTST
- LCS4K70BTOL
- LCS1570TPOL
- LCS1870TPST
- LCS4K70TPOL
- UDI-DI: 00821925040137
- 00821925040151
- 00821925040144
- 00821925040175
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Olympus Corporation of the Americas
See all →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateOlympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults
FDA (Devices) · 2026-07-29
- HighOlympus High Flow Insufflation Unit UHI-4 Recalled Due to Display and Air Delivery Failure
FDA (Devices) · 2026-07-29
- HighOlympus Toomey Evacuator 30cc medical device sterilization parameters recalled
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
Same hazard · device breakage
See all →- HighTissium Peripheral Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighPeripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighTissium COAPTIUM CONNECT Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighSurgify Halo Surgical Burr Breakage Risk During Spinal Surgery
FDA (Devices) · 2026-07-01
- SevereSurgify Halo 4.0mm Extendable Surgical Burr Recall for Breakage Risk
FDA (Devices) · 2026-07-01