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InstaClear LCS1800UNSTRecalls & reported problems

Gyrus ACMI, LLC · SHEATH, LENS CLEANER STORZ 0 DEGREES for use with Storz 4 x 180 mm scopes, UNIVERSAL LIGHT InstaClear (5/PK) · Class 2

All models of InstaClear (19)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925040069), received between Aug 1, 2022 and Aug 1, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K152531); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

  1. Apr 3, 2024Open, Classified

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

    Z-1888-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

  • Contamination1
  • Device Contaminated During Manufacture or Shipping1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 1, 2022Contamination; Device Contaminated During Manufacture or Shipping; Contamination; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED THAT WHEN CUSTOMER TOOK OUT THE PRODUCT, " BLACK THINGS" DESCRIBED AS "LIKE A LUMP OF POWDER FOUND " IN THE STERILITY PACK. THE DEVICE WAS REPLACED WITH SIMILAR DEVICE. THE ISSUE FOUND DURING PREPARATION FOR USE FOR A THERAPEUTIC OTORHINOLARYNGOLOGY SURGERY. THE INTENDED PROCEDURE WAS COMPLETED WITH SIMILAR DEVICE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15142045 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152531. One submission often covers many models, so check the product and lot details in each record.

  • Z-1368-2024 · Jan 16, 2024 · Open, Classified
    InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LC

Other NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) devices

All NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page