Reported Mar 8, 2023 · Terminated

Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.

Summit Medical, LLC

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: Summit Medical, LLC · 815 Vikings Pkwy Ste 100 · Eagan, MN · 55121-1139

Is this the product you have?

  • Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Lot codes and dates
    • Lot #219349
    • Exp. 2027-11-01
    • UDI (01)00385640065214(17)271101(10)219340
Amount recalled
30 devices

Where it was sold

Why it was recalled

Sterile product pouches were not sealed.

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

Notice updated Aug 14, 2026 · 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.