CooperSurgical, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1421-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055

Product Classification:

Class II

Date Initiated: June 13, 2022

Date Posted: July 27, 2022

Recall Number: Z-1421-2022

Event ID: 90469

Reason for 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.

Status: Ongoing

Product Quantity: 403 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated