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CUSA Clarity C7000 Console
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MEDICAL DEVICE RECALLMODERATE

CUSA Clarity C7000 Console

Integra LifeSciences is recalling CUSA Clarity C7000 Console (Software 2.1.1.909) due to unresponsive touch screen.

What to do

Stop using the affected console immediately. Contact Integra LifeSciences at the recall hotline for software update instructions or device replacement.

Recalled
Listed
Updated
Recall No.
Z-1828-2026
Agency
FDA
Firm
Integra LifeSciences Corp. (NeuroSciences)
Recall ID
98476
Status
ONGOING

Recall at a glance

Quantity recalled
78 units

Why it was recalled

Integra LifeSciences is recalling the CUSA Clarity C7000 Console with Software Version 2.1.1.909 due to a software issue that renders the touch screen unresponsive, potentially affecting surgical workflow and patient safety.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.

UDI-DI
10381780126232

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification