FDA recall Z-1314-2023

Fujifilm Irvine Scientific, Inc. · Class II · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-01-16
Report date
2023-04-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Ana, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1314-2023