FDA Device recall Z-0998-2024
Sperm separation media are used to separate motile sperm from other constituents of semen
- FDA Device
- Class II
- ongoing
- Published 2024-02-14
On 2024-02-14 the FDA classified a Class II recall of Sperm separation media are used to separate motile sperm from other constituents of semen by Fujifilm Irvine Scientific, citing 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)….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0998-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-02 |
| Published | 2024-02-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fujifilm Irvine Scientific |
| Distribution | AR, CA, DC, FL, IA, IL, IN, LA, MI, MN, NC, NJ, NV, NY, OK, OR, PA, TX, UT, WA, WI, WV |
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).
Identifiers
| code_info | UDI-DI: 00857515006009, Lot 0000020693 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0998-2024%22
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