CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report
Sperm separation media are used to separate motile sperm recalled
Fujifilm Irvine Scientific is recalling Sperm separation media are used to separate motile sperm from other constituents of semen, distributed in 22 states. The recall was initiated on 2 Nov 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0998-2024
- FDA event ID
- 93726
- Recalling firm
- Fujifilm Irvine Scientific, Santa Ana, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Nov 2023
- FDA classified
- 6 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 2 Nov 2023 | Recall initiated by company | |
| 6 Feb 2024 | Classified by FDA | +96 days |
| 14 Feb 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Sperm separation media are used to separate motile sperm from other constituents of semen.
Where it was distributed
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
ArkansasCaliforniaDistrict of ColumbiaFloridaIowaIllinoisIndianaLouisianaMichiganMinnesotaNorth CarolinaNew JerseyNevadaNew YorkOklahomaOregonPennsylvaniaTexasUtahWashington
Questions about this recall
Why was it 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).
Which lots are affected?
UDI-DI: 00857515006009, Lot 0000020693
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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