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Lower risk Medical device recall · FDA · Published February 13, 2023

CooperS: Global Total LP embryo culture medium recall - Incorrect protein source risk

CooperSurgical recalls 60mL Global Total LP embryo culture medium that may lack required protein for embryo development. Affected units have specific lot numbers and reference codes.

🇺🇸 FDA recall #Z-1348-2023Medical deviceCooperSurgical ›
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Recalling firmCooperSurgical, Inc.95 Corporate Dr · Trumbull, CT 06611-1350
✎ GovInfoNow plain-language explainer

CooperSurgical is recalling a specific embryo culture medium that may not contain the necessary protein for embryo development. This could affect fertility treatments where precise media composition is critical. Read more at govinfonow.com/recall/58907-coopers-global-total-lp-embryo-culture-medium-recall-incorrect-protein.

Source Summary by GovInfoNow · govinfonow.com/recall/58907-coopers-global-total-lp-embryo-culture-medium-recall-incorrect-protein · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1348-2023

Cite this page

“CooperS: Global Total LP embryo culture medium recall - Incorrect protein source risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58907-coopers-global-total-lp-embryo-culture-medium-recall-incorrect-protein. Based on FDA recall #Z-1348-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1348-2023%22&limit=1).

CooperSurgical, Inc. recalled Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer on Feb. 13, 2023, according to the FDA. The agency said the product may contain a medium lacking the required protein source for embryo culture and development.

How to tell if you have it

  • Brand: CooperSurgical
  • Product: Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer
  • Reference Number: H5GT-060
  • UDI-DI: 00815965020433
  • LOT: 221118-010694
  • Units affected: 190

The hazard

The FDA said the affected product may contain a medium other than the specified Global Total LP single step medium. This incorrect medium does not contain the protein source required for embryo culture and development.

Context

GovInfoNow's records show CooperSurgical, Inc. has had 37 other recalls on record since Oct. 6, 2017. Other recent recalls include the INCA Infant Nasal CPAP (Aug. 11, 2026), Endosee System Convenience Kit with IV Tube (June 11, 2025), and K-Systems T47 Warming Plate (Nov. 15, 2024).

How to tell if you have this one

Check for the reference number H5GT-060 on the product label. Affected units have lot numbers starting with 221118-010694.

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

What to do — step by step

  1. Check Product Label

    Look for the reference number H5GT-060 and lot number starting with 221118-010694 on the product label.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 2 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: named in the noticeUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of NY, UT and the countries of Argentina, Belgium, Bulgaria, Ecuador, France, Germany, Hong Kong, Italy, Malaysia, Mexico, Peru, Singapore, Spain, Switzerland, Thailand, Turkey, the…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: New York, Utah.

Recall timeline

FDA published this recall 58 days after the firm started it.

1. Firm started the recall: Feb 13, 202312. FDA classified it Class II: Apr 6, 202323. Published in FDA’s Enforcement Report: Apr 12, 202332023
  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-1348-2023 (February 13, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1348-2023 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