Fujifilm Irvine Scientific, Inc.
Fujifilm Irvine Scientific, Inc. has 3 FDA enforcement events on this register (4 product records) between 2021 and 2023: 3 device; the busiest year was 2023 with 2.
0% of its events are Class I; the most common class is Class II (3). 3 events are listed as ongoing; the recalling firm's address is in CA.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 2 Nov 2023 | Sperm separation media are used to separate motile sperm from other constituents of semen. | Device | Class II | 1 | Ongoing |
| 16 Jan 2023 | Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305 | Device | Class II | 1 | Ongoing |
| 8 Sep 2021 | 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 Vitrification Thaw Kit (Vit Kit-Thaw)… | Device | Class II | 2 | Ongoing |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Fujifilm Irvine Scientific, Inc. had?
3 enforcement events (4 product records) on this register, 2021–2023: 3 device.
Are any Fujifilm Irvine Scientific, Inc. recalls ongoing?
3 events are listed as ongoing in the current openFDA export.
What class are Fujifilm Irvine Scientific, Inc. recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.