LifeGlobal Fast Freeze Thawing Kit — Class II medical device recall Z-1421-2022
Ongoing recall by CooperSurgical, Inc., reported 2022-07-27, distributed in AL, AZ, CA, CT, FL, GA, ID, IL…. There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to
| Recall number | Z-1421-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2022-06-13 |
| Classified | 2022-07-20 |
| Reported by FDA | 2022-07-27 |
| Distributed | 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 |
| Countries outside the US | BE, CA, ES, HR, NL, PT |
| Quantity | 403 units |
| Reason classes | temperature control |
| UPC / GTIN / UDI-DI | 00815965020914 |
| Lot numbers | 21335060, GFT5-200218U, GFT5-201026U |
| Model numbers | GFT5-055 |
Product
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1421-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.