CooperSurgical, Inc. LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Brand
CooperSurgical, Inc.
Lot Codes / Batch Numbers
GFT5-200218U, GFT5-201026U
Products Sold
UDI: (01)00815965020914 (17)220819 (10)GFT5-200218U (01)00815965020914 (17)220819 (10)GFT5-201026U (01)00815965020914 (17)220819 (10)GFT5-21335060 Lots: 21335060, GFT5-200218U, GFT5-201026U
CooperSurgical, Inc. is recalling LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055 due to 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 m. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On June 13, 2022, the firm distributed Urgent Media Safety Notice letters to affected customers. Customers were informed that setting out a thawing blastocyte for 5 minutes may be detrimental to the survival of the blastocyte. Customers were asked to complete and return an acknowledgement form. Once the firm has received the completed form, they will provide the corrected IFU.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
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
Page updated: Jan 10, 2026