Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Sperm separation media are used to separate motile sperm from Recalled by Fujifilm Irvine Scientific, Inc. Due to The lower layer component of a sperm separation...

Date: November 2, 2023
Company: Fujifilm Irvine Scientific, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Fujifilm Irvine Scientific, Inc. directly.

Affected Products

Sperm separation media are used to separate motile sperm from other constituents of semen.

Quantity: 246

Why Was This Recalled?

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).

Where Was This Sold?

This product was distributed to 22 states: AR, CA, FL, IL, IN, IA, LA, MI, MN, NV, NJ, NY, NC, OK, OR, PA, TX, UT, WA, WV, WI, DC

Affected (22 states)Not affected

About Fujifilm Irvine Scientific, Inc.

Fujifilm Irvine Scientific, Inc. has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report