Irvine Scientific embryo culture oil recalled due to detected toxicity
Fujifilm Irvine Scientific is recalling its Oil for Embryo Culture product due to detection of oil toxicity in several manufacturing lots. A total of 15,131 bottles are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for detected oil toxicity in a reproductive medicine product. No illnesses or adverse outcomes have been reported; the hazard is theoretical. Per the rubric, when no illnesses are reported and the hazard is theoretical, the maximum score is 3 (High).
Plain-English summary
Irvine Scientific Oil for Embryo Culture (Light Mineral Oil, Catalog #9305) is being recalled by Fujifilm Irvine Scientific, Inc. due to the detection of oil toxicity in several manufacturing lots. A total of 15,131 bottles have been identified as part of this recall.
The product is used in embryo culture procedures during assisted reproductive treatments. The detection of oil toxicity presents a potential hazard to the integrity and viability of embryos being cultured. No patient illnesses or adverse outcomes have been reported to date.
The affected product was distributed throughout the United States, including to all 50 states and Washington D.C., as well as to international customers in India, Israel, Japan, Malaysia, Mexico, South Korea, South Africa, Thailand, Vietnam, Brazil, Bosnia, Argentina, Netherlands, and the United Kingdom. Affected lot numbers include 0000011351, 0000011367, 0000015999, and 0000016001.
Fertility clinics and laboratories using this product should immediately discontinue use and contact Fujifilm Irvine Scientific, Inc. for return and replacement options.
The recalled product
- Product
- Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
- Manufacturer
- Fujifilm Irvine Scientific, Inc.
- Hazard
- oil-toxicity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 9305-500ml / 0000011367
- 9305-100ml / 0000015999
- 9305-500ml / 0000016001
Distribution
Distributed in 35 states:
- 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
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