Z-1089-2024Class II

global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle)

Name: Z-1089-2024 global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle)
Creator: CooperSurgical, Inc.
Published: 2023-12-20
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2023-12-20 / Open, Classified

FDA source

CooperSurgical, Inc. began a recall of 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... on 2023-12-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1089-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-20
Posted: 2024-02-14
Recalling firm: CooperSurgical, Inc.
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.
Product code: MQL Media, Reproductive
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.
FDA root cause: Under Investigation by firm
Action: On December 13, 2023, the firm notified customers via Urgent Media Recall Field Safety Notice letters. Customers were instructed to quarantine affected product and respond to the recall notice. The firm will arrange for the return of affected product and customers will receive credit for returned affected product. If you have additional questions, please email CooperSurgical Recall at [email protected]. Alternately, please contact a CooperSurgical Product Surveillance representative at +1 203.601.5200 Ext. 3300.
Quantity in commerce: 994 total (481 US; 513 OUS)
Distribution: 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.
Product codes and lots: LGGG-020: UDI-DI 00815965020044, lot 231020-018741 LGGG-050: UDI-DI 00815965020051, lot 231020-018742 LGGG-100: UDI-DI 00815965020068, lot 231020-018743

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1089-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1089-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-14

Product code MQL

K142991Class IILifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSALife Global Group, LLC / cleared 2015-02-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)