Reported Feb 21, 2024 · Ongoing

global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use:…

CooperSurgical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350

Is this the product you have?

    • global Medium
    • Model Numbers LGGG-020 (20mL bottle)
    • LGGG-050 (50mL bottle)
    • LGGG-100 (100mL bottle)
  • Intended useCulture of human embryos from zygote to blastocyst, embryo transfer
Lot codes and dates
  • LGGG-020UDI-DI 00815965020044
  • lot 231020-018741 LGGG-050UDI-DI 00815965020051
  • lot 231020-018742 LGGG-100
    • UDI-DI 00815965020068
    • lot 231020-018743
Amount recalled
994 total (481 US; 513 OUS)

Where it was sold

Why it was recalled

The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:40 PM UTC

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