Reported Aug 6, 2025 · Ongoing

Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682…

Institut Georges Lopez

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: INSTITUT GEORGES LOPEZ · 6 ROUTE DE SAINT BONNET · ST LAURENT DE CHAMOUSSET · N/A

Is this the product you have?

  • Brand NameCelsior
  • Cold Storage Solution Product NameCelsior Cold
  • Storage Solution Model/Catalog Number533682
  • Product DescriptionIn 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)
Lot codes and dates

7 of 7 products

Products covered by this recall
#BarcodesProduct as published
12370091190012313700911900126Lot Code: UDI carton box: 23700911900123 & UDI bag: 13700911900126 (for US
2reference). The product
3reference recalled in France is different and there is no UDI on this one (not required for medicine in France). Batches concerned by the recall are the following
4Lot SL240261-1
5Lot SL240266-1
6Lot SL240272-1
7Lot SL240280-2 These batches have been sold only in France
Amount recalled
1,532 units

Why it was recalled

The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:55 PM UTC

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