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Recall

Class II — Fujifilm Irvine Scientific, Inc.

Recalling firmIRVINE SCIENTIFIC LLC
Registered facilityIRVINE SCIENTIFIC LLC (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonDue to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
ProductIrvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Quantity15,131 bottles
DistributionU.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 Kingdom
Initiated2023-01-16
Classified2023-03-30
Recall numberZ-1314-2023
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Fujifilm Irvine Scientific, Inc. (Z-1314-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91557/

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