FUJIFILM Irvine Scientific issues recall for embryo culture oil after “impaired embryo development”

FUJIFILM Irvine Scientific has issued a recall notice for their “Oil for Embryo Culture (Light Mineral Oil)” (catalog number 9305) after complaints of reduced blastocyst development, and in some cases degenerated embryos. The affected lots include 0000011351, 0000011367, 0000015999 and 0000016001.

“The affected lots of Oil for Embryo Culture may result in impairment of embryo development and result in poor blastocyst development or non-transferable blastocyst, resulting in the inability to perform the procedure”

This type of oil can be used during a number of IVF procedures, such as during ICSI or the culture of embryos.

Embryos are cultured in specialized liquid called “culture media” that contains nutrients and factors needed for development. The pH and concentration of salts and nutrients in this liquid (osmolality) are critical to the culture media’s performance. Oil is often placed on top of the culture media, and acts to protect this lower layer from evaporation that would alter the pH/osmolality. The oil keeps the culture media’s performance more stable.

Two dishes containing culture media drops which are overlaid with mineral oil. Modified from Louanjli et al. (2021)CC BY-SA 4.0.

FUJIFILM Irvine Scientific has detected toxicity in the above indicated lots, but not in Lot 0000011367, which they warn was still derived from the same raw material lot. Out of caution, this lot is being recalled also.

The company released this statement on January 16, 2023, but a Los Angeles couple have filed a recent lawsuit that alleges this oil destroyed their embryos on February 16, as reported by the Los Angeles Times.

This recall was done quietly and the notice was not posted on their website or announced to the public, the LA Times reports. IVF clinics and distributors would have received the notice on January 16.

A company representative said the affected lots go back as far as August 2022. So if anyone had a retrieval or had eggs or embryos thawed between August 2022 and January 16, 2023, it’s a good idea to contact your clinic to make sure they didn’t use this particular oil.

FUJIFILM Irvine Scientific is a global company and supplies this product and others to IVF clinics all around the world.

I’ve made a post about this on my social media channels, and the Instagram post in particular has a number of clinics responding directly to patients about this, while others are not responding. This is a good place to tag your clinic, if you’re using Instagram.

Here’s a list of clinics or patients of a particular clinic that have responded to my Instagram post or in my Facebook group and indicated they don’t use this product (note this is NOT an official list, and some of these clinics may be large and have multiple locations, so it’s possible that one location used the affected lots while others didn’t — the best thing to do is ask your clinic for confirmation!):

  • Pacific Northwest Fertility
  • Dr. Aimee Eyvazzadeh
  • Anova Fertility
  • CNY Fertility
  • San Diego Fertility Center
  • Reproductive Partners Medical Group
  • CCRM Fertility
  • Fertility Treatment Center
  • Reproductive Partners
  • Kindbody
  • Conceptions Baby
  • The Evewell
  • Advanced IVF
  • Spring Fertility
  • RMA
  • Midwest Fertility Specialists
  • New Direction Fertility Center
  • Markham Fertility Centre
  • Life IVF Center
  • ACRM
  • TRIO Fertility
  • RADfertility
  • Fertility North
  • Davies Fertility & IVF Specialists
  • Pacific Fertility Center Los Angeles
  • Fertility Center of Southern California
  • Boston IVF
  • Aurora Reproductive Care
  • George Washington University IVF

I’ll keep monitoring the Instagram post for updates that will be added here. You can also comment below, or send an email to embryoman@remembryo.com, to confirm whether or not any clinic has used this oil. Your best bet is to contact your clinic if you had a retrieval or had eggs or embryos thawed between August 2022 and January 16, 2023.