Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1314-2023

January 16, 2023

Class II

Product summary

Firm
Fujifilm Irvine Scientific, Inc.
Event
Event 91557
Status
Ongoing
Classification
Class II
Quantity
15,131 bottles
Official record key
device-enforcement:Z-1314-2023

Official wording

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

Code information: UDI-Di Code: 08937270029305TH Catalog Number / Lot Numbers: 9305-100ml / 0000011351, 9305-500ml / 0000011367, 9305-100ml / 0000015999, 9305-500ml / 0000016001

Distribution pattern: 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 Kingdom

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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