Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LifeGlobal Fast Freeze Thawing Kit Recalled by CooperSurgical, Inc. Due to There was translation error in the Spanish version...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CooperSurgical, Inc. directly.
Affected Products
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Quantity: 403 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 31 states: AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, MD, MA, MI, MN, MO, MT, NE, NV, NJ, NY, NC, OH, OK, OR, PA, SC, TX, UT, VT, WA, WI
About CooperSurgical, Inc.
CooperSurgical, Inc. has 83 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report