Sperm separation media are used to separate motile sperm from other… — Class II medical device recall Z-0998-2024
Ongoing recall by Fujifilm Irvine Scientific, Inc., reported 2024-02-14, distributed in AR, CA, DC, FL, IA, IL, IN, LA…. The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should
| Recall number | Z-0998-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fujifilm Irvine Scientific, Inc., Santa Ana, CA, United States |
| Recall initiated | 2023-11-02 |
| Classified | 2024-02-06 |
| Reported by FDA | 2024-02-14 |
| Distributed | AR, CA, DC, FL, IA, IL, IN, LA, MI, MN, NC, NJ, NV, NY, OK, OR, PA, TX, UT, WA, WI, WV |
| Quantity | 246 |
| UPC / GTIN / UDI-DI | 00857515006009 |
| Lot numbers | 0000020693 |
Product
Sperm separation media are used to separate motile sperm from other constituents of semen.
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0998-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.