SARASOTA, Fla. — An ice cream linked to more than 20 hospitalizations and a death has been recalled.

On Wednesday, the FDA announced that Big Olaf Creamery is recalling all flavors and lots of its ice cream products because they have the potential to be contaminated with Listeria monocytogenes. The ice cream was sold at Big Olaf retailers in Florida as well as to consumers in restaurants and senior homes, and one location in Fredericksburg, Ohio.

The recall comes after WFLA reports that several environmental samples from a Big Olaf ice cream processing facility tested positive for listeria. The Florida Department of Agriculture and Consumer Services issued a stop-use order of the equipment where listeria was found, effectively shutting down the facility.

The ice cream was sold in plastic pint size containers, plastic ½ gallon containers, and plastic 2.5-gallon tubs. Other product was sold to independent retail stores. All flavors, lots, codes, and all expiration dates through 6/30/2022 are included in the recall.

The FDA reports that based on information from the CDC and state officials, Big Olaf may be a potential source of illnesses in an ongoing Listeria outbreak.

Listeria monocytogenes is a bacterium that can cause the serious infection Listeriosis. It can also cause common food poisoning symptoms.

The CDC says around 1,600 people get listeriosis every year, resulting in about 260 deaths. It is most likely to sicken pregnant women and their newborns, adults 65 and older, and people with weakened immune systems.

As of July 8, a total of 23 people infected with the outbreak strain of Listeria monocytogenes have been reported from 10 states. 12 of those infected are residents of Florida and another nine reported traveling to Florida before getting sick.

Of the people who have gotten sick, 22 people have been hospitalized, and one death has been reported in Illinois. Five pregnant people got sick, resulting in the loss of one of the pregnancies.

The age range of the people infected goes from younger than one to 92 years old, with a median age of 72. More than half of those infected are male.

The CDC says recent illnesses may not be reported, as it usually takes three to four weeks to determine if a sick person is part of an outbreak. The true number of people involved in this outbreak is likely higher than the reported amount, as some people recover without medical care and are not tested.

The FDA said Big Olaf is cooperating with regulatory authorities to return all suspected products. In a prior statement, the company said while the company is cooperating with the ongoing investigation, “it is only speculation” that their ice cream is the culprit.

Regarding the investigation for possible listeria contamination:

For now it is only speculation as it is an ongoing investigation, our brand has not been confirmed to be linked to these cases. I am not sure why only Big Olaf is being mentioned and targeted. The original report we got from the Florida Department of Health on Friday, July 1st, was that there are 23 cases reported, the first one reported was January 2022. 6 out of the 23 patients mentioned having consumed Big Olaf ice cream, but nothing has been proven. We have been cooperating with the Florida Department of Health, FDACS, and the FDA as soon as we were informed about the situation. We have been transparent and have answered all their questions and provided them with all the information requested from us, as the health and wellbeing of the public is our first priority.

– Big Olaf Creamery via Instagram

The CDC says public health investigators are using a system that manages a national database of DNA fingerprints of bacteria to identify illnesses that may be part of this outbreak. This same method was used to identify the source of the Jif peanut butter Salmonella outbreak.

The investigation showed that bacteria from sick people’s samples are closely related genetically. The CDC says this means people in the outbreak likely got sick from the same food.

Big Olaf faces two lawsuits connected to the outbreak. WFLA reports one is for the death of an Illinois woman and another from a couple who said they lost their unborn child because of the listeria infection.

Anyone with the recalled ice cream should throw it out. Any areas, containers and serving utensils that may have touched the ice cream should be cleaned. Anyone with questions about the recall can call (941) 365-7483, Monday through Saturday from 8:00am – 5:00 pm EST.