Integra Footswitch Recall: Unintended Ultrasonic Activation Risk
Integra LifeSciences recalls Footswitch (C7000) for CUSA Clarity system due to risk of unintended ultrasonic tissue fragmentation during surgery. Affected units include specific lots.
Use caution until it’s fixed
A faulty footswitch may result in unintended ultrasonic fragmentation activation. There are two scenarios when the failure mode may occur: 1) Ultrasonic fragmentation may be inadvertently activated at start-up or at the initial use once the footswitch is connected to the console and after the user primes the system, performs a handpiece test, and enters the Main Screen. 2) Ultrasonic fragmentation may remain activated during surgical use once the foot pedal is disengaged slowly.
Contact the company
What happened, in plain English
Integra LifeSciences is recalling a footswitch accessory for their CUSA Clarity Ultrasonic Tissue Ablation System. The footswitch may activate ultrasonic fragmentation unexpectedly during surgery, potentially causing tissue damage. This recall affects specific model numbers and lots. Read more at govinfonow.com/recall/72943-integra-footswitch-recall-unintended-ultrasonic-activation-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/72943-integra-footswitch-recall-unintended-ultrasonic-activation-risk · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0694-2018
Cite this page
“Integra Footswitch Recall: Unintended Ultrasonic Activation Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72943-integra-footswitch-recall-unintended-ultrasonic-activation-risk. Based on FDA recall #Z-0694-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0694-2018%22&limit=1).
Why it’s dangerous
The footswitch may activate ultrasonic fragmentation unexpectedly during two scenarios: when the system starts up after initial setup, or while the foot pedal is slowly disengaged during surgery. This can cause unintended tissue fragmentation, potentially leading to injury.
Who’s affected
Surgical professionals using the CUSA Clarity system with the recalled footswitch (model C7000) are most at risk. Patients undergoing procedures involving the affected footswitch could face unintended tissue fragmentation.
How to tell if you have this one
Check for the C7000 footswitch model. Affected units include specific lots: 1885744, 1923802, 1985221, 2057996, 2109587, 2118507. The product is used with the CUSA Clarity Ultrasonic Tissue Ablation System in surgical procedures.
- Brand
Integra LifeSciences- Category
Medical device
What to do — step by step
Check Footswitch Model
Identify the model number on the footswitch to confirm if it's C7000.
Contact Manufacturer
Reach out to Integra LifeSciences for guidance on next steps for affected units.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 32 states.
FDA distribution: “Worldwide Distribution - US Nationwide in 33 states: AL, AR, CA, CO, CT, FL, GA, IA, ID, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NM, NY, OH, OK, OR, PA, TN, TX, VA, WA, WI in the countries of Greece, South Africa, France,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0694-2018 (September 26, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0694-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.