CUSA Clarity C7000 Console — Class II medical device recall Z-1828-2026
Ongoing recall by Integra LifeSciences Corp. (NeuroSciences), reported 2026-04-29, distributed nationwide. Software issue that renders the touch screen unresponsive.
| Recall number | Z-1828-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ, United States |
| Recall initiated | 2026-03-06 |
| Classified | 2026-04-17 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, CN, CZ, DE, ES, FI, FR, GB, IT, JP, LU, NL, PL, TN |
| Quantity | 78 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10381780126232 |
| Serial numbers | CHA1902101IE, CHA2001301IE, CHA2001401IE, CHA2002301IE, CHA2202301IE, CHA2305101IE, CHA2305401IE, CHA2307001IE, CHA2402201IE, CHB1711001IE, CHB1723601IE, CHB2000801IE, CHB2100901IE, CHB2301401IE, CHB2500101IE, CHC1800601IE, CHC1902601IE, CHC1902701IE, CHC2001201IE, CHD1705801IE, CHD1707101IE, CHD1801001IE, CHD1801101IE, CHD1902501IE, CHE1707201IE and 53 more |
| Model numbers | C7000 |
Product
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Reason for recall
Software issue that renders the touch screen unresponsive.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1828-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.