---
title: "Sperm separation media are used to separate motile sperm from other constitue... — FDA record Z-0998-2024 | Is It on Recall"
description: "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:"
url: https://isitonrecall.com/recall/fda-device-z-0998-2024-sperm-separation-media-are-used-to-separate-motile-sperm-from-other-constituents-of-semen/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## 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

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0998-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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.

- [Arkansas](https://isitonrecall.com/state/arkansas/)
- [California](https://isitonrecall.com/state/california/)
- [District of Columbia](https://isitonrecall.com/state/district-of-columbia/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Iowa](https://isitonrecall.com/state/iowa/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [Louisiana](https://isitonrecall.com/state/louisiana/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [Minnesota](https://isitonrecall.com/state/minnesota/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [Nevada](https://isitonrecall.com/state/nevada/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Oklahoma](https://isitonrecall.com/state/oklahoma/)
- [Oregon](https://isitonrecall.com/state/oregon/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Utah](https://isitonrecall.com/state/utah/)
- [Washington](https://isitonrecall.com/state/washington/)
- [Wisconsin](https://isitonrecall.com/state/wisconsin/)
- [West Virginia](https://isitonrecall.com/state/west-virginia/)

## 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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0998-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Fujifilm Irvine Scientific, Inc. records](https://isitonrecall.com/brand/fujifilm-irvine-scientific-inc/)