Coopersurgical issues December 2023 recall of embryo culture media

CooperSurgical issued a recall for its global embryo culture media (part number LGGG-100, LGGG-050 and LGGG-020) on December 5, 2023, with affected lots being 231020-018743, 231020-018742 and 231020-018741. The recall can be accessed here (pdf download).

Cooper owns a ton of the IVF market (and yes, does PGT-A as CooperGenomics), and manufactures different culture media for IVF. This media that is recalled is used in culturing embryos. Many clinics around the world use this media. It’s not intended specifically for PGT-A, but for growing embryos in general.

In mid-December, a lawsuit was filed against CooperSurgical over defective embryo culture media that was allegedly toxic for eggs, sperm and embryos.

The plaintiffs, based in California, had a donor egg retrieval and 34 fertilized eggs on day 1. None of these fertilized eggs progressed to blastocyst on day 5 or 6, and “should have resulted in 20 blastocysts” based on the donor’s age, according to the clinic’s embryologist.

One blastocyst did eventually develop, the lawsuit states, however this embryo was tested to be chromosomally abnormal after PGT-A.

The lab director initiated an investigation with seperate labs and found other instances of failed embryo development, with the same embryo culture media being a common factor.

After formal complaint, a recall notice was issued by Cooper. This notice was sent only to fertility clinics and not to patients.

I found the CooperSurgical recall notice (pdf download) online from the national authorization and supervisory authority Swissmedic. The recall was dated December 5, 2023, and lists their global® media, which is used to culture embryos from days 1 to 5.

The recall lists part numbers LGGG-100, LGGG-050 and LGGG-020, with the affected lots being 231020-018743, 231020-018742 and 231020-018741.

I can’t confirm when these lots were manufactured, but the global® product data sheet indicates that the shelf life for this product is 10 weeks from the date of manufacture, which spans 2.5 months. The affected dates seem to be November and early December of 2023, according to attorney Tracey Cowan, who is representing patients affected.

Since originally posting this in early January 2024, there have been more lawsuits filed, including one law firm which is representing about 60 clients, and another public law firm which is representing more. Additionally, a class action lawsuit has been filed in Canada against CooperSurgical.

“There are still couples out there who have no idea that their cycle was impacted by this. We do know that there are at least hundreds, if not thousands, of families across the country who have been impacted by this and had not only their financial situation wiped out, but also their hopes and dreams of parenthood,” said Tracey Cowan, attorney at Clarkson Law Firm.

The source of the problem seems to be a lack of magnesium in the culture media, which is needed for embryo growth. CooperSurgical “continued to manufacture embryo culture media despite the empty magnesium hopper [on the assembly line], and as a result, produced embryo culture media that lacked a nutrient critical for embryonic development,” a lawsuit reads.

If you’ve had any strange results over the past few months, you should consider contacting your clinic to see if this media was used.

Here’s some additional points raised on social media that I’ve addressed. These aren’t official responses from the company, but are based on my experience as a former embryologist and understanding of the process. This information may not be 100% accurate and I encourage you to ask your clinic for verification.

• It can be used for thaws.
• It doesn’t appear to be used for retrievals, only to culture embryos after fertilization to blastocyst. So eggs that degrade after retrieval may not be affected, since this media wouldn’t typically be used until after fertilization.
• If embryos make it to blastocyst, it’s not clear if there’s any impact on further development/implantation potential. The recall states that embryos’ health to the blastocyst stage is impaired, so it seems to prevent embryos from becoming blastocysts.
• I don’t know the manufacturing date, but based on the time of the recall and the expiration date of the product, it seems that this would only affect cycles toward the end of 2023.

If you have any further information, let me know and I’ll update this post! You can send an email to embryoman@remembryo.com, or comment on the Instagram post.