Safety recall
Medical
FDA
Is the Medtronic Custom Perfusion kits, with the following… safe?
Medtronic Perfusion Systems · Recalled Oct 12, 2021
No — the Medtronic Custom Perfusion kits, with the following… was recalled on Oct 12, 2021 due to a safety issue. Product is labeled as non-pyrogenic but endotoxin testing was not performed. If you have this product: Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
Why it was recalled
Product is labeled as non-pyrogenic but endotoxin testing was not performed.
What to do
Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
View the official FDA recall →
This is an official recall published by FDA. Recall details are current as of 2026-06-25; verify the latest status at the source.
Medtronic Custom Perfusion kits, with the following…: common questions
Is the Medtronic Custom Perfusion kits, with the following… safe?
No. The Medtronic Custom Perfusion kits, with the following… was recalled on Oct 12, 2021 due to a safety issue. Product is labeled as non-pyrogenic but endotoxin testing was not performed.
Has the Medtronic Custom Perfusion kits, with the following… been recalled?
Yes. The Medtronic Custom Perfusion kits, with the following… was recalled on Oct 12, 2021. The recall was issued by FDA (recall ID Z-0491-2022).
Why was the Medtronic Custom Perfusion kits, with the following… recalled?
Product is labeled as non-pyrogenic but endotoxin testing was not performed.
What should I do if I have the Medtronic Custom Perfusion kits, with the following…?
Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
Where can I find the official recall notice for the Medtronic Custom Perfusion kits, with the following…?
The official FDA recall record is available
here. Always verify recall details with the official source.
TinySafe is an independent app and is not affiliated with, endorsed by, or sponsored by the FDA or CPSC. Always confirm recall details with the official source. The absence of a recall does not guarantee a product is safe.
