Fujifilm Irvine Scientific, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0998-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 2, 2023

Date Posted: February 14, 2024

Recall Number: Z-0998-2024

Event ID: 93726

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).

Status: Ongoing

Product Quantity: 246

Code Information:

UDI-DI: 00857515006009, Lot 0000020693

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated