Lower risk Medical device recall · FDA · Published June 13, 2022

CooperSurgical LifeGlobal Fast Freeze Thawing Kit Recall: Spanish IFU Translation Error

CooperSurgical recalls LifeGlobal Fast Freeze Thawing Kit Model GFT5-055 due to Spanish instructions incorrectly stating 5-minute air thaw instead of 5 seconds. This could lead to improper freezing.

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

🇺🇸 FDA recall #Z-1421-2022Medical device CooperSurgical ›

Lower-risk recall

There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version.

Take action

Contact the company

Recalling firmCooperSurgical, Inc.95 Corporate Dr · Trumbull, CT 06611-1350

✎ GovInfoNow plain-language explainer

CooperSurgical is recalling LifeGlobal Fast Freeze Thawing Kit Model GFT5-055 because the Spanish version of the user manual says to air thaw for 5 minutes instead of the correct 5 seconds. This error could cause improper freezing of samples. Read more at govinfonow.com/recall/60511-coopersurgical-lifeglobal-fast-freeze-thawing-kit-recall-spanish-ifu-translation.

Source Summary by GovInfoNow · govinfonow.com/recall/60511-coopersurgical-lifeglobal-fast-freeze-thawing-kit-recall-spanish-ifu-translation · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1421-2022

Cite this page

“CooperSurgical LifeGlobal Fast Freeze Thawing Kit Recall: Spanish IFU Translation Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60511-coopersurgical-lifeglobal-fast-freeze-thawing-kit-recall-spanish-ifu-translation. Based on FDA recall #Z-1421-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1421-2022%22&limit=1).

CooperSurgical, Inc. recalled LifeGlobal Fast Freeze Thawing Kits due to a translation error in the Spanish instructions that incorrectly advises users to air thaw blastocytes for five minutes instead of five seconds, according to the FDA. The agency announced the voluntary Class II recall on June 13, 2022.

How to tell if you have it

Brand: CooperSurgical
Product: LifeGlobal Fast Freeze Thawing Kit
Model No.: GFT5-055
UPC: 00815965020914
Lots: 21335060, GFT5-200218U, GFT5-201026U

The hazard

The hazard involves a translation error in the Spanish version of the Instructions for Use (IFU) that instructs users to leave the blastocyte to air thaw for five minutes rather than the correct five seconds indicated in the English version.

Context

GovInfoNow's records show CooperSurgical, Inc. has 37 other recalls on record since October 6, 2017. Other recent recalls include an Infant Nasal CPAP set recalled on August 11, 2026, due to potential loose tubing connections, and Endosee System Convenience Kits recalled on June 11, 2025, for non-sterile iodine pouches mislabeled as sterile. A K-Systems G73 Dry Bath Incubator was also recalled on November 15, 2024, due to overheating risks.

How to tell if you have this one

Check for the model number GFT5-055 on the kit. The kit was sold with specific lot numbers and UDI codes listed in the recall notice.

Brand
CooperSurgical
Product
CooperSurgical, Inc. recalls LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Review Spanish Instructions
Check if the Spanish version of the user manual says to air thaw for 5 minutes instead of 5 seconds.

Where it went and when

Where it was distributed

Distributed in 31 states, and outside the U.S.

FDA distribution: “Domestic: USA AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TX, UT, VT, WA, WI, International: Belgium, Canada, Croatia, Netherlands, Portugal, Spain” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Utah, Vermont, Washington, Wisconsin.

Recall timeline

FDA published this recall 44 days after the firm started it.

Jun 13, 2022Firm started the recall
Jul 20, 2022FDA classified it Class II
Jul 27, 2022Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/60511-coopersurgical-lifeglobal-fast-freeze-thawing-kit-recall-spanish-ifu-translation">CooperSurgical LifeGlobal Fast Freeze Thawing Kit Recall: Spanish IFU Translation Error (GovInfoNow)</a>

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-1421-2022 (June 13, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1421-2022 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.