Fujifilm Irvine Scientific, Inc. FDA Recalls

4 recalls on file across devices, 0 of them Class I and 4 still open. Matched by name to FUJIY.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Sperm separation media are used to separate motile sperm from other constituents of semen.Class IINov 2, 2023The lower layer component of a sperm separation Kit does not	The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should	Class IIDevices	Nov 2, 2023
Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305Class IIJan 16, 2023Due to the detection of oil toxicity in several lots of Oil	Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.	Class IIDevices	Jan 16, 2023
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MClass IISep 8, 2021Due to a component in kit being labeled with the incorrect E	Due to a component in kit being labeled with the incorrect Expiration Date	Class IIDevices	Sep 8, 2021
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MClass IISep 8, 2021Due to a component in kit being labeled with the incorrect E	Due to a component in kit being labeled with the incorrect Expiration Date	Class IIDevices	Sep 8, 2021