Reported Jul 3, 2024 · Completed

Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101

Aspen Surgical

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: ASPEN SURGICAL · 5120 Beltway Dr Se · Caledonia, MI · 49316

Is this the product you have?

  • Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Lot codes and dates
  • UDI-DI00840113214006
  • Lot Numbers
    • 389571
    • 389576
    • 390981
    • 390982
Amount recalled
1900 units

Where it was sold

  • Nationwide

Why it was recalled

The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.

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

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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, 7:00 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.