Reported Jul 3, 2024 · Ongoing

CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification…

Integra LifeSciences Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Integra LifeSciences Corp. · 1100 Campus Rd · Princeton, NJ · 08540-6650

Is this the product you have?

  • CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration
  • of soft and hard tissue Catalog NumberC2600* *Note: you may see C2600P or C2600SRL on labeling. This notice is applicable for those SKUs as well
Lot codes and dates
  • UDI-DI10381780039419 All serial numbers distributed before 12/14/2023 Product manufactured before 11/01/2023
  • SNHandpiece manufactured Prior to HAL23XXXXXXIE (represents a product
  • that is manufactured in November 2023)HA indicating the product family Letter indicating the month of manufacture where A = January; B = February, L=November. Two digits e.g 23 indicating the year of manufacture with 23 representing 2023
Amount recalled
2, 652 units

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.