Recall archive / FDA device enforcement
Sperm separation media are used to separate motile sperm from other constituents of semen. — FDA record Z-0998-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 2, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Sperm separation media are used to separate motile sperm from other constituents of semen.
- Reason
- 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).
- Classification
- Class II
- Recalling firm
- Fujifilm Irvine Scientific, Inc.
- Quantity
- 246
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0998-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00857515006009, Lot 0000020693 |
Match all identifying details in the current notice. A brand name alone is not enough.
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 below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 14, 2024
- Recall initiation date
- Nov 2, 2023
- Center classification date
- Feb 6, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.