global Medium embryo culture media recalled for potential development impairment
CooperSurgical is recalling three specific lots of global Medium embryo culture media distributed to fertility clinics worldwide due to performance issues that may impair embryo development during culture.
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: This is a Class II medical device recall with no reported illnesses or injuries, only performance issues that may theoretically impair embryo development. Per the severity rubric, recalls with risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
CooperSurgical, Inc. is recalling specific lots of global Medium embryo culture media (model numbers LGGG-020, LGGG-050, and LGGG-100) used in embryo culture for assisted reproductive technology. The recalled lots are 231020-018741 (20mL), 231020-018742 (50mL), and 231020-018743 (100mL).
The firm identified a sudden increase in complaints for these lots indicating performance issues. These performance issues may lead to impaired embryo development prior to the blastocyst stage during culture.
The culture media were distributed to facilities in the United States and internationally. US distribution includes 481 units across 38 states. International distribution includes 513 units to Canada, Brazil, Mexico, Argentina, and over 20 other countries spanning Europe, Asia, and the Middle East.
This is a Class II recall.
The recalled product
- Product
- global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- developmental-defect
- culture-media-defect
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 (4)
- LGGG-020: UDI-DI 00815965020044
- lot 231020-018741 LGGG-050: UDI-DI 00815965020051
- lot 231020-018742 LGGG-100: UDI-DI 00815965020068
- lot 231020-018743
Distribution
Distributed nationwide across the United States.
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