Irvine Scientific Oil for Embryo Culture — Class II medical device recall Z-1314-2023
Ongoing recall by Fujifilm Irvine Scientific, Inc., reported 2023-04-05, distributed in AR, AZ, CA, CT, DC, FL, HI, IA…. Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
| Recall number | Z-1314-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fujifilm Irvine Scientific, Inc., Santa Ana, CA, United States |
| Recall initiated | 2023-01-16 |
| Classified | 2023-03-30 |
| Reported by FDA | 2023-04-05 |
| Distributed | AR, AZ, CA, CT, DC, FL, HI, IA, ID, IL, IN, KS, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WI, WV |
| Countries outside the US | AR, BR, GB, IL, IN, JP, KR, MX, MY, NL, TH, VN, ZA |
| Quantity | 15,131 bottles |
| Lot numbers | 0000011351, 0000011367, 0000015999, 0000016001, 9305-100ML, 9305-500ML |
| Model numbers | 9305 |
Product
Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Reason for recall
Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1314-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.