Class II — Integra LifeSciences Corp. (NeuroSciences)
| Recalling firm | Integra LifeSciences Corporation |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Software issue that renders the touch screen unresponsive. |
| Product | CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system. |
| Quantity | 78 units |
| Distribution | Worldwide - US Nationwide distribution in the states of MI & NY. The countries of Belgium, China, Czechia, Dubai, Finland, France, Germany, Italy, Japan, Luxembourg, Netherlands. Poland, Spain, Switzerland, Tunisia & United Kingdom. |
| Initiated | 2026-03-06 |
| Classified | 2026-04-17 |
| Recall number | Z-1828-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Integra LifeSciences Corp. (NeuroSciences) (Z-1828-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98476/
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