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Lower risk Medical device recall · FDA · Published December 20, 2023

CooperSurgical Recalls Embryo Culture Bottles Due to Potential Development Risks

CooperSurgical recalls three embryo culture bottle models (20mL, 50mL, 100mL) after reports of impaired embryo development. Affected units may need replacement to prevent issues during early embryonic growth.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1089-2024Medical deviceCooperSurgical ›
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Contact the company

Recalling firmCooperSurgical, Inc.95 Corporate Dr · Trumbull, CT 06611-1350
✎ GovInfoNow plain-language explainer

CooperSurgical is recalling three sizes of embryo culture bottles (20mL, 50mL, 100mL) because some units may cause embryo development problems before the blastocyst stage. This could affect fertility treatments if the bottles are used improperly. Read more at govinfonow.com/recall/56528-coopersurgical-recalls-embryo-culture-bottles-due-to-potential-development-risks.

Source Summary by GovInfoNow · govinfonow.com/recall/56528-coopersurgical-recalls-embryo-culture-bottles-due-to-potential-development-risks · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1089-2024

Cite this page

“CooperSurgical Recalls Embryo Culture Bottles Due to Potential Development Risks.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56528-coopersurgical-recalls-embryo-culture-bottles-due-to-potential-development-risks. Based on FDA recall #Z-1089-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1089-2024%22&limit=1).

The FDA announced on Dec. 20, 2023, that CooperSurgical, Inc. is recalling global Medium culture media due to performance issues that may impair embryo development. The agency issued recall number Z-1089-2024 for the voluntary Class II action.

How to tell if you have it

  • Brand: CooperSurgical
  • Product: global Medium
  • Model LGGG-020 (20mL bottle), UDI-DI 00815965020044, lot 231020-018741
  • Model LGGG-050 (50mL bottle), UDI-DI 00815965020051, lot 231020-018742
  • Model LGGG-100 (100mL bottle), UDI-DI 00815965020068, lot 231020-018743
  • Distribution: Worldwide including US states 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 countries 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, Germany

The hazard

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.

Context

GovInfoNow's records show CooperSurgical, Inc. has 37 other recalls on record since 2017-10-06. Other recent recalls of similar products include CooperSurgical Neonatal CPAP Replacement Set (2026-08-11), CooperSurgical Endosee System Convenience Kit Recall (2025-06-11), and K-Systems T47 Warming Plate Recall (2024-11-15). Other recent recalls of similar products include Medline IVS Blood Culture Kits Recall (2026-06-12), Medline Convenience Kits Recall (2026-01-07), and Medline IV Start Kits Recalled Due to Sterility Risk in Packaging (2026-06-12).

How to tell if you have this one

Check for model numbers LGGG-020 (20mL), LGGG-050 (50mL), or LGGG-100 (100mL) on the bottle. The recall covers specific production lots with UDI-DI numbers 00815965020044, 00815965020051, and 00815965020068.

  • Brand
    CooperSurgical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Bottle Model

    Identify the model number on the bottle to see if it matches LGGG-020, LGGG-050, or LGGG-100.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 33 states.

Alaska: nationwideAKMaine: nationwideMEVermont: named in the noticeVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Missouri, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Dec 20, 202312. FDA classified it Class II: Feb 14, 202423. Published in FDA’s Enforcement Report: Feb 21, 2024320232024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1089-2024 (December 20, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1089-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA