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Lower risk Medical device recall · FDA · Published January 16, 2024

Olympus InstaClear Lens Cleaner Recall: Japanese Instructions May Cause Lens to Fall

Olympus recalls InstaClear Lens Cleaners (models LCS1500UNOL to LCS4K70TPOL) due to Japanese instructions differing from English version, potentially causing lens to fall during surgery.

🇺🇸 FDA recall #Z-1368-2024Medical deviceOlympus ›
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Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
✎ GovInfoNow plain-language explainer

Olympus is recalling several models of InstaClear Lens Cleaners used in endoscopic sinus surgery because Japanese instructions differ from English instructions. This could cause the lens to fall during procedures, posing a risk to patients. Read more at govinfonow.com/recall/56313-olympus-instaclear-lens-cleaner-recall-japanese-instructions-may-cause-lens.

Source Summary by GovInfoNow · govinfonow.com/recall/56313-olympus-instaclear-lens-cleaner-recall-japanese-instructions-may-cause-lens · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1368-2024

Cite this page

“Olympus InstaClear Lens Cleaner Recall: Japanese Instructions May Cause Lens to Fall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56313-olympus-instaclear-lens-cleaner-recall-japanese-instructions-may-cause-lens. Based on FDA recall #Z-1368-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1368-2024%22&limit=1).

The FDA announced on Jan. 16, 2024, that Olympus Corporation of the Americas is recalling InstaClear Lens Cleaner devices due to a hazard where tips and plates may fall off. The agency cited inconsistent instructions for use between Japanese and English versions as the cause.

How to tell if you have it

  • Brand: Olympus
  • Product: InstaClear Lens Cleaner
  • Model Numbers: LCS1500UNOL, LCS1800UNST, LCS4K00UNOL, LCS1530BTOL, LCS1830BTST, LCS4K30BTOL, LCS1530TPOL, LCS1830TPST, LCS4K30TPOL, LCS1545BTOL, LCS1845BTST, LCS4K45BTOL, LCS1545TPOL, LCS1845TPST, LCS4K45TPOL, LCS1570BTOL, LCS1870BTST, LCS4K70BTOL, LCS1570TPOL, LCS1870TPST, LCS4K70TPOL
  • Distribution: Japan

The hazard

According to the FDA, the Japanese Instructions for Use (IFU) had slightly different language and illustrations from the English IFU. This discrepancy could contribute to the tip and plate falling off during use.

Context

GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since Aug. 18, 2017. Other recent recalls include the Olympus Tripp-Lite P580-025 DisplayPort Cable (Aug. 27, 2026), the Olympus M3 Gold Autoclavable Foroblique Telescope 30 (Aug. 24, 2026), and the Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector (Aug. 19, 2026). Other recent recalls of similar products include the Olympus OER-Pro (Oct. 31, 2025), the TECNIS Eyhance IOL with Simplicity Delivery System (Feb. 19, 2026), and the Canon Alphenix INFX-8000F X-Ray System (Dec. 19, 2025).

How to tell if you have this one

Check for model numbers LCS150: LCS1500UNOL, LCS1800UNST, LCS4K00UNOL, and other variants listed in the recall notice. These products were sold with Japanese instructions that differ from the English instructions.

  • Brand
    Olympus
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Model

    Identify your InstaClear Lens Cleaner model from the list provided in the recall notice.

How this recall unfolded

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Jan 16, 202412. FDA classified it Class II: Mar 22, 202423. Published in FDA’s Enforcement Report: Apr 3, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-1368-2024 (January 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1368-2024 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA