Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold… — Class II medical device recall Z-2220-2025
Ongoing recall by INSTITUT GEORGES LOPEZ, reported 2025-08-06. The potential for risk of microbiological contamination of products due to inability to ensure sterility assur
| Recall number | Z-2220-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | INSTITUT GEORGES LOPEZ, ST LAURENT DE CHAMOUSSET, France |
| Recall initiated | 2025-03-13 |
| Classified | 2025-07-30 |
| Reported by FDA | 2025-08-06 |
| Countries outside the US | FR |
| Quantity | 1,532 units |
| Reason classes | microbial contamination, sterility |
| UPC / GTIN / UDI-DI | 13700911900126, 23700911900123 |
| Lot numbers | L240261-1, L240266-1, L240272-1, L240280-2 |
| Model numbers | 533682 |
Product
Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in one liter bag with 4 units per carton box. Celsior shall be stored between 36¿ to 46¿F. In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).
Reason for recall
The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
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-2220-2025. 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.