# FDA recall Z-0998-2024

> **Fujifilm Irvine Scientific, Inc.** · Class II · device recall initiated 2023-11-02.

## 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).

## 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

## Key facts

- **Recall number:** Z-0998-2024
- **Recalling firm:** Fujifilm Irvine Scientific, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-02
- **Report date:** 2024-02-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Ana, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0998-2024

## Citation

> AI Analytics. FDA recall Z-0998-2024. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0998-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*