Lower riskMedical device recall · FDA · Published November 2, 2023
Fujifilm Sperm Separation Kits Recalled: Incorrect Lot Numbers May Cause Inaccurate
Fujifilm Irvine Scientific recalls sperm separation kits with incorrect lot numbers that may lead to inaccurate sperm analysis results. Affected kits contain wrong lower layer components as per certificate of analysis.
The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) but incorrectly may contain lower layer (Lot number 9925811106, Shelf Life: 30 November 2023).
Take action
Contact the company
📍Recalling firmFujifilm Irvine Scientific, Inc.2511 Daimler St · Santa Ana, CA 92705-5533
“Fujifilm Sperm Separation Kits Recalled: Incorrect Lot Numbers May Cause Inaccurate.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56965-fujifilm-sperm-separation-kits-recalled-incorrect-lot-numbers-may-cause. Based on FDA recall #Z-0998-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0998-2024%22&limit=1).
Fujifilm Irvine Scientific, Inc. recalled Sperm separation media kits on Nov. 2, 2023, according to the FDA. The hazard is that the lower layer component does not match the certificate of analysis.
How to tell if you have it
Brand: Fujifilm Irvine Scientific
Product: Sperm separation media
UDI-DI: 00857515006009
Lot: 0000020693
The hazard
The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) but incorrectly may contain lower layer (Lot number 9925811106, Shelf Life: 30 November 2023).
Context
GovInfoNow's records show Fujifilm Irvine Scientific, Inc. has two other recalls on record since Sept. 8, 2021. Other recent recalls of similar products include Changchun Wancheng Male Fertility Sperm Test Cassette (Nov. 22, 2025) and Medline Convenience Kits Recall: Calibration Issues May Affect Sterility (Jan. 7, 2026).
How to tell if you have this one
Check the lower layer lot number on the kit. Correct kits should have lot number 0000020686 with shelf life until December 31, 2024. Incorrect kits may have lot number 9925811106 with shelf life until November 30, 2023.
Brand
Fujifilm Irvine Scientific
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for the lower layer lot number on the kit. Correct kits should have lot number 0000020686 with shelf life until December 31, 2024.
Where it went and when
Where it was distributed
Distributed in 20 states and D.C..
Listed by the agency
Not listed
FDA distribution: “US: OK, CA, DC, NC, NV, TX, MI, IN, NY, UT, WI, MN, PA, WV, NJ, IL, LA, WA, OR, FL, IA. OUS: GB, NL, AR, MY” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, District of Columbia, Florida, Illinois, Indiana, Iowa, Louisiana, Michigan, Minnesota, Nevada, New Jersey, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, Texas, Utah, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0998-2024 (November 2, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0998-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.