FDA Device recall Z-1828-2026
CUSA Clarity C7000 Console, Software Version: 2.1.1.909
- FDA Device
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of CUSA Clarity C7000 Console, Software Version: 2.1.1.909 by Integra Lifesciences Neurosciences, citing software issue that renders the touch screen unresponsive.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1828-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-06 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Integra Lifesciences Neurosciences |
| Distribution | US |
Product
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Reason
Software issue that renders the touch screen unresponsive.
Identifiers
| code_info | Model: C7000; UDI: 10381780126232; Serial Numbers: CHA1902101IE, CHA2001301IE, CHA2001401IE, CHA2002301IE, CHA2202301IE…Model: C7000; UDI: 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, CHE1707301IE, CHE2203301IE, CHE2204001IE, CHE2301001IE , CHE2305001IE, CHE2502901IE, CHE2503101IE, CHE2503201IE, CHE2503401IE, CHE2503701IE, CHF1701401IE, CHF1702701IE, CHF2100701IE, CHF2303701IE, CHF2305401IE, CHG1700101IE, CHG1700801IE, CHG1902401IE, CHG2000201IE, CHG2000301IE, CHG2204101IE, CHG2402301IE, CHG2502801IE, CHG2506001IE, CHH1802901IE, CHH2402801IE, CHH2500601IE, CHJ2001101IE, CHJ2001301IE , CHJ2301201IE, CHJ2304601IE, CHK1700801IE, CHK1702301IE, CHK1703001IE, CHK2402601IE, CHK2403401IE, CHK2404101IE, CHL1701701IE, CHL1900201IE, CHL2102901IE , CHL2103001IE, CHL2301301IE, CHL2302 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1828-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.