Reported Apr 24, 2019 · Terminated

Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC

Gyrus ACMI, Inc.

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: Gyrus ACMI, Inc. · 2925 Appling Rd · Bartlett, TN · 38133-3901

Is this the product you have?

  • Diego Elite Turbinate Blades Bipolar Blade, 4mm straight
  • Part NoBB4000SC
Lot codes and dates
  • All lot numbers
Amount recalled
82

This recall covers 10 products

The agency filed one notice per product. You are reading one of them; the other 9 are below.

Where it was sold

  • Nationwide

Why it was recalled

Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Gyrus ACMI, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated May 8, 2020 · Data as of Sep 19, 5:45 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.