Use caution Medical device recall · FDA · Published April 3, 2024

Olympus InstaClear Lens Sheath Recall: Risk of Sheath Breaking Off During Surgery

Olympus recalls InstaClear Lens Sheaths (models LCS4K30BTOL, LCS1530TPOL, etc.) due to potential for distal end to break off during procedures, which could cause injury. Affected units sold in the U.S. from 2019 onward.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1888-2024Medical device Olympus ›

Use caution until it’s fixed

Potential for distal end of the sheath to break off during a procedure.

Take action

Contact the company

Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229

✎ GovInfoNow plain-language explainer

Olympus is recalling InstaClear Lens Sheaths because the distal end of the sheath might break off during surgery. This could lead to injury if the broken piece enters the nasal cavity. The recall affects specific models sold since 2019. Read more at govinfonow.com/recall/55670-olympus-instaclear-lens-sheath-recall-risk-of-sheath-breaking-off.

Source Summary by GovInfoNow · govinfonow.com/recall/55670-olympus-instaclear-lens-sheath-recall-risk-of-sheath-breaking-off · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1888-2024

Cite this page

“Olympus InstaClear Lens Sheath Recall: Risk of Sheath Breaking Off During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55670-olympus-instaclear-lens-sheath-recall-risk-of-sheath-breaking-off. Based on FDA recall #Z-1888-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1888-2024%22&limit=1).

Olympus Corporation of the Americas recalled InstaClear Lens Sheath due to the potential for the distal end to break off during a procedure, according to the FDA on April 3, 2024.

How to tell if you have it

Brand: Olympus
Product: InstaClear Lens Sheath
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
Lot: All Lot Numbers

The hazard

The distal end of the sheath may break off during a procedure.

Context

GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since 2017-08-18. Other recent recalls include Olympus Tripp-Lite P580-025 DisplayPort Cable (2026-08-27), Olympus M3 Gold Autoclavable Foroblique Telescope 30 (2026-08-24), and Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector (2026-08-19). Other recent recalls of similar products include Oscor Abiomed Introducer Kit Recall (2026-06-10), Abiomed Impella CP Introducer Kit Recall (2026-06-11), and Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (2026-03-03).

How to tell if you have this one

Check for model numbers: LCS4K30BTOL, LCS1530TPOL, LCS1830TPST, LCS4K30TPOL, LCS1545BTOL, LCS1845BTST, LCS4K45BTOL, LCS1545TPOL, LCS1845TPST, LCS4K45TPOL, LCS1570BTOL, LCS1870BTST, LCS4K70BTOL, LCS1570TPOL, LCS1870TPST, LCS4K70TPOL. These sheaths were sold in the U.S. starting in 2019.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Numbers
Look for model numbers on the sheath: LCS4K30BTOL, LCS1530TPOL, LCS1830TPST, LCS4K30TPOL, LCS1545BTOL, LCS1845BTST, LCS4K45BTOL, LCS1545TPOL, LCS1845TPST, LCS4K45TPOL, LCS1570BTOL, LCS1870BTST, LCS4K70BTOL, LCS1570TPOL, LCS1870TPST, LCS4K70TPOL.
Contact Olympus
If you have the recalled sheath, contact Olympus Corporation of the Americas for instructions on how to return it or get a replacement.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Domestic: Nationwide Distribution; Foreign: Australia, Canada, Germany, Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 56 days after the firm started it.

Apr 3, 2024Firm started the recall
May 23, 2024FDA classified it Class II
May 29, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/55670-olympus-instaclear-lens-sheath-recall-risk-of-sheath-breaking-off">Olympus InstaClear Lens Sheath Recall: Risk of Sheath Breaking Off During Surgery (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1888-2024 (April 3, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1888-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.