LifeGlobal Media recallZ-1089-2024 · CooperSurgical, Inc. · initiated Dec 20, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CooperSurgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1089-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 20, 2023
- Posted by the FDA
- Feb 14, 2024
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 994 total (481 US; 513 OUS)
- Product code
- MQL
- FDA submissions
- K142991
- 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 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.
Code information (models, lots, serial numbers)
LGGG-020: UDI-DI 00815965020044, lot 231020-018741 LGGG-050: UDI-DI 00815965020051, lot 231020-018742 LGGG-100: UDI-DI 00815965020068, lot 231020-018743
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- LifeGlobal® Media LGGG-020Lifeglobal Group, LLC · MEDIA, REPRODUCTIVE1 recall0 reports
- LifeGlobal® Media LGGG-050Lifeglobal Group, LLC · MEDIA, REPRODUCTIVE1 recall0 reports
- LifeGlobal® Media LGGG-100Lifeglobal Group, LLC · MEDIA, REPRODUCTIVE1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K142991 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- LifeGlobal® Media H5GT-060Lifeglobal Group, LLC · MEDIA, REPRODUCTIVE1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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