Integra LifeSciences Corp. recalls AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Prod…
- Recall date
- February 6, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1295-2025
- FDA classification
- Class II
- Brand / firm
- Integra LifeSciences Corp.
- Sold / distributed
- US Nationwide distribution in the states of MO, FL, TX, NY, IL, OH, NJ, CA, MN, WA, TN, MD, LA, OK, SC, PA, MI, KY, NC, DC.
Why it was recalled
Possibility for the obturator to break (separate).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
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