The Recall Desk

Manufacturer

Fujifilm Irvine Scientific, Inc.

4 recalls in our database name Fujifilm Irvine Scientific, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2024-02-14

Of the 4 recalls from Fujifilm Irvine Scientific, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–4 of 4

  • ModerateFDA (Devices)·Z-0998-2024·2024-02-14

    Sperm separation media kits recalled for incorrect component lot

    Fujifilm is recalling sperm separation media kits because the lower layer component may not match the documented lot. The kits may contain an older component with a different shelf life, which could affect product performance.

    Product
    Sperm separation media are used to separate motile sperm from other constituents of semen.
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-1314-2023·2023-04-05

    Irvine Scientific embryo culture oil recalled due to detected toxicity

    Fujifilm Irvine Scientific is recalling its Oil for Embryo Culture product due to detection of oil toxicity in several manufacturing lots. A total of 15,131 bottles are affected.

    Product
    Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-0248-2022·2021-11-24

    Reproductive Medical Device Recalled for Incorrect Expiration Date Labeling

    Fujifilm Irvine Scientific is recalling Vit Kit-Freeze, a medical device used in assisted reproductive procedures, due to kit components being labeled with incorrect expiration dates.

    Product
    Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0249-2022·2021-11-24

    Vitrification Freeze Kit Recalled Due to Incorrect Expiration Date Labeling

    Fujifilm Irvine Scientific is recalling Vit Kit-Freeze due to incorrect expiration date labeling on a component. The incorrect label could lead to use of degraded solutions in assisted reproductive procedures.

    Product
    Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and
    Category
    Medical Device
    Distribution
    Distributed nationwide