Medical device recalls Moderate risk

Fujifilm Irvine Scientific, Inc. recalls Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305

Recall date
January 16, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1314-2023
FDA classification
Class II
Brand / firm
Fujifilm Irvine Scientific, Inc.
Sold / distributed
U.S.: AZ, AR, CA, CT, DC, FL, HI, IA, ID, IL, IN, KS, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WI and WV. O.U.S.: India, Israel, Japan, Malaysia, Mexico, South Korea, South Africa, Thailand, Vietnam, Brazil, Bosnia, Argentina, Netherlands, and United Kingd…

Why it was recalled

Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305

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