Biopsy Medium for In Vitro Fertilization Recalled Due to Product Contamination
CooperSurgical is recalling a lot of Biopsy Medium used in IVF procedures because the product may contain an incorrect medium that could degrade embryos. No illnesses have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involving a risk-of-harm medical device (embryo viability) with no reported illnesses or injuries. Per the rubric, risk-of-harm products without reported injury receive a score of 3.
Plain-English summary
CooperSurgical, Inc. is recalling Biopsy Medium 10ML (Reference Number 10620010 A, Lot Number 220506-006557) used for embryo biopsy and pre-implantation genetic diagnosis in in vitro fertilization procedures. A total of 489 units have been affected by this recall.
The affected product may contain a medium other than the intended Biopsy Medium. There is a risk that use of this product from the recalled lot could cause degradation of the embryo.
The product has been distributed globally to 29 countries including Bahrain, Belgium, Bulgaria, Egypt, France, Georgia, Greece, Hong Kong, Iran, Iraq, Israel, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Nigeria, Oman, Pakistan, Poland, Republic of North Macedonia, Saudi Arabia, Slovenia, Spain, Thailand, Turkey, Turkmenistan, and United Arab Emirates.
No illnesses or adverse events have been reported in connection with this recall. The FDA has classified this as a Class II recall.
The recalled product
- Product
- BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 489
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 (1)
- Lot Number: 220506-006557
Distribution
Distribution scope not specified by the agency.
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