Z-1828-2026Class II

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

Name: Z-1828-2026 CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system
Creator: Integra LifeSciences Corp. (NeuroSciences)
Published: 2026-03-06
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2026-03-06 / Open, Classified / root cause: software

FDA source

Integra LifeSciences Corp. (NeuroSciences) began a recall of CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system on 2026-03-06. FDA classified it as Class II and gives the reason as "Software issue that renders the touch screen unresponsive". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1828-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-06
Posted: 2026-04-17
Recalling firm: Integra LifeSciences Corporation
Product: CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Product code: LFL Instrument, Ultrasonic Surgical
Reason for recall: Software issue that renders the touch screen unresponsive.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: An URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION notice dated 3/6/26 was sent to consignees. The notice instructs consignees to restart systems when freeze to restore functionality of the touchscreen capabilities for 8 minutes; this action may be used multiple times. Integra's Service and Repair can provide remote support to disable and re-enable the write filter with Integra employees and/or Authorized service personnel. This will reset the console to provide approximately 28 days with no touchscreen issue. Integra Lifesciences Service Team will contact consignees within 5 to 10 business days to schedule correction of affected devices at no cost. Consignees with any questions can direct them to Customer Service by emailing [email protected] or by phone at 1-800-654-2873.
Quantity in commerce: 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.
Product codes and lots: 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, CHL2302001IE, CHL2302101IE, CHL2403301IE, CHM1901901IE, CHM2100101IE, CHM2101601IE, CHM2200201IE, CHM2200301IE, CHM2200501IE, CHM2300701IE, CHM2402101IE.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1828-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1828-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17

Product code LFL

K161882UnclassifiedCUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation / cleared 2016-10-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)