CooperSurgical, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1089-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 20, 2023

Date Posted: February 21, 2024

Recall Number: Z-1089-2024

Event ID: 93688

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 994 total (481 US; 513 OUS)

Code Information:

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 Pattern:

Worldwide - US Nationwide including in the states of AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MO, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, TN, TX, UT, VT, VA, WA, WV and the countries of Canada, Brazil, Mexico, Argentina, Hong Kong, Japan, Turkey, Netherlands, Belgium, Spain, Taiwan, United Kingdom, Austria, Georgia, France, Denmark, Greece, Saudi Arabia, Thailand, New Zealand, Estonia, Poland, Jordan, and Germany.

Voluntary or Mandated:

Voluntary: Firm initiated