Z-1314-2023Class II

Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305

Name: Z-1314-2023 Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Creator: Fujifilm Irvine Scientific, Inc.
Published: 2023-01-16
License: https://open.fda.gov/license/

FUJIFILM Biosciences Inc. / initiated 2023-01-16 / Open, Classified / root cause: manufacturing process

FDA source

Fujifilm Irvine Scientific, Inc. began a recall of Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305 on 2023-01-16. FDA classified it as Class II and gives the reason as "Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1314-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-01-16
Posted: 2023-04-01
Recalling firm: FUJIFILM Biosciences Inc.
Product: Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Product code: MQL Media, Reproductive
Reason for recall: Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 01/16/2023, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that, the firm has received complaints of reduced blastocyst development, including complete degradation in some cases, during culture of human embryos. Additionally, some clinics performed Human Sperm Survival Assay (HSSA), as part of incoming confirmatory Quality Control testing, and reported low sperm motility. Customers are instructed to: 1. Immediately stop using the product; 2. Quarantine any remaining product in inventory; 3. Return or destroy the product; 4. Complete and return the enclosed MEDICAL DEVICE RETURN RESPONSE FORM; and 5. Email the completed MEDICAL DEVICE RETURN RESPONSE FORM to [email protected] by January 23, 2023. For questions, contact: Customer Service Manager, Medical Business: - Toll free in the US: 1.800.577.6097 - Phone: 1.949.261.7800 x457 - Email: Melissa Gomez, [email protected]
Quantity in commerce: 15,131 bottles
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, Vietnam, Brazil, Bosnia, Argentina, Netherlands, and United Kingdom
Product codes and lots: UDI-Di Code: 08937270029305TH Catalog Number / Lot Numbers: 9305-100ml / 0000011351, 9305-500ml / 0000011367, 9305-100ml / 0000015999, 9305-500ml / 0000016001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1314-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1314-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-30

Product code MQL

K011938Class IIOil for Embryo CultureIrvine Scientific Sales Co., Inc. / cleared 2001-07-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)