Integra LifeSciences Corp. (NeuroSciences) recalls CUSA Clarity C7000 Console
Reason for recall
Software issue that renders the touch screen unresponsive.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Lot / code information
- Model
- C7000
- UDI
- 10381780126232
- Serial #
CHA1902101IE, CHA2001301IE, CHA2001401IE, CHA2002301IE, CHA2202301IE, CHA2305101IE — +72 moreShow all
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
What the firm is doing
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 custsvcnj@integralife.com or by phone at 1-800-654-2873.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1828-2026
- FDA 510(k) clearance · K161882The device's official FDA premarket clearance record
- FDA device classification · LFLOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Integra LifeSciences Corp. (NeuroSciences)Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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