Recall Z-1828-2026 ยท LFL Instrument, Ultrasonic Surgical
Integra LifeSciences Corp. (NeuroSciences)
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
| Date | Apr 17, 2026 (initiated Mar 6, 2026) |
| Status | Open, Classified |
| Reason | Software issue that renders the touch screen unresponsive. |
| 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 t |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161882 | CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation, Oct 14, 2016 |