LifeGlobal Media recallZ-1421-2022 · CooperSurgical, Inc. · initiated Jun 13, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CooperSurgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Error in labeling
What the company is doing
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.
Recall details
- Recall number
- Z-1421-2022
- Status
- Open, Classified
- Initiated by the company
- Jun 13, 2022
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 403 units
- Product code
- MQL
- FDA submissions
- K092963
- 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
Product description
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LifeGlobal® Media GFT5-055Lifeglobal Group, LLC · MEDIA, REPRODUCTIVE1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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