MediCult Vitrification Cooling Media — Class II medical device recall Z-0100-2021
Terminated recall by CooperSurgical, Inc., reported 2020-10-21. There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging.
| Recall number | Z-0100-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2020-09-08 |
| Classified | 2020-10-13 |
| Reported by FDA | 2020-10-21 |
| Terminated | 2021-01-11 |
| Countries outside the US | CN |
| Quantity | 531 boxes |
| Reason classes | labeling |
| Lot numbers | 20230080 |
| Model numbers | 12284001F |
Product
MediCult Vitrification Cooling Media, Model Number 12284001F
Reason for recall
There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrification Medium (P/N: 12230001) as indicated on the remainder of the label.
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-0100-2021. 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.