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Lower risk Medical device recall · FDA · Published January 16, 2023

Fujifilm Irvine Scientific Oil for Embryo Culture Recall: Oil Toxicity Risk

Fujifilm Irvine Scientific recalls Light Mineral Oil for Embryo Culture (REF Catalog #9305) due to detected oil toxicity in some lots. Affected products include specific 100ml and 500ml sizes with listed lot numbers.

🇺🇸 FDA recall #Z-1314-2023Medical deviceFujifilm Irvine Scientific ›
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Contact the company

Recalling firmFujifilm Irvine Scientific, Inc.2511 Daimler St · Santa Ana, CA 92705-5533
✎ GovInfoNow plain-language explainer

Fujifilm Irvine Scientific is recalling Light Mineral Oil for Embryo Culture products because some lots contain toxic oil. This could harm embryos during IVF procedures if used improperly. Read more at govinfonow.com/recall/59030-fujifilm-irvine-scientific-oil-for-embryo-culture-recall-oil-toxicity.

Source Summary by GovInfoNow · govinfonow.com/recall/59030-fujifilm-irvine-scientific-oil-for-embryo-culture-recall-oil-toxicity · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1314-2023

Cite this page

“Fujifilm Irvine Scientific Oil for Embryo Culture Recall: Oil Toxicity Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59030-fujifilm-irvine-scientific-oil-for-embryo-culture-recall-oil-toxicity. Based on FDA recall #Z-1314-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1314-2023%22&limit=1).

The FDA announced on Jan. 16, 2023, that Fujifilm Irvine Scientific is recalling Oil for Embryo Culture due to detected oil toxicity. The agency issued the voluntary Class II recall after identifying hazardous lots of the product.

How to tell if you have it

  • Brand: Fujifilm Irvine Scientific
  • Product: Irvine Scientific Oil for Embryo Culture (Light Mineral Oil)
  • Catalog #: 9305
  • Lot codes: 0000011351, 0000011367, 0000015999, 0000016001

The hazard

The recall is due to the detection of oil toxicity in several lots of Oil for Embryo Culture products. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show Fujifilm Irvine Scientific, Inc. has two other recalls on file since Sept. 8, 2021, including a Nov. 2, 2023, recall of Sperm Separation Kits for incorrect lot numbers and a Sept. 8, 2021, recall of Vit Kit-Freeze for incorrect expiration dates. Other recent recalls of similar products include Arrow Medical Kits Recall (April 21, 2026), Arrow Biopsy System Kits Recall (April 21, 2026), and Arrow Paracentesis Kit Recall (April 21, 2026).

How to tell if you have this one

Check for the REF Catalog #9305 on the product label. Look for specific lot numbers: 0000011351 (100ml), 0000011367 (500ml), 0000015999 (100ml), and 0000016001 (500ml).

  • Brand
    Fujifilm Irvine Scientific
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the REF Catalog #9305 and specific lot numbers listed in the recall.

Where it went and when

Where it was distributed

Distributed in 34 states and D.C., and outside the U.S.

Alaska: not listedAKMaine: yesMEVermont: not listedVTNew Hampshire: yesNHWashington: not listedWAIdaho: yesIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: not listedORNevada: yesNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: not listedCONebraska: yesNEMissouri: yesMOKentucky: not listedKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “U.S.: AZ, AR, 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 and WV. O.U.S.: India, Israel, Japan, Malaysia, Mexico, South Korea, South Africa, Thailand,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Arkansas, California, Connecticut, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Jan 16, 202312. FDA classified it Class II: Mar 30, 202323. Published in FDA’s Enforcement Report: Apr 5, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1314-2023 (January 16, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1314-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA