Use cautionMedical device recall · FDA · Published November 1, 2018
LivaNova SORIN Heater-Cooler System 3T Recall: Disinfectant Risk
LivaNova recalls SORIN Heater-Cooler System 3T models with potential disinfectant inefficiency and aerosol emission risks. Affected units may need repair or replacement to ensure patient safety during medical procedures.
The firm has become aware that due to a chemical reaction, the disinfectant/water preservative used to disinfect the device to inhibit/limit the growth micro-organisms, may be rendered ineffective. In addition, the firm is releasing a design upgrade to reduce the risk of potential emission of aerosols from the 3T.
Take action
Contact the company
📍Recalling firmLivaNova USA Inc.14401 W 65th Way · Arvada, CO 80004-3503
✎ GovInfoNow plain-language explainer
LivaNova is recalling SORIN Heater-Cooler System 3T medical devices due to a risk that the disinfectant may become ineffective, potentially allowing microorganisms to grow. This could lead to infections during surgeries if the device is not properly maintained. The recall also includes a design upgrade to reduce aerosol emissions. Read more at govinfonow.com/recall/69531-livanova-sorin-heater-cooler-system-3t-recall-disinfectant-risk.
“LivaNova SORIN Heater-Cooler System 3T Recall: Disinfectant Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69531-livanova-sorin-heater-cooler-system-3t-recall-disinfectant-risk. Based on FDA recall #Z-0220-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0220-2020%22&limit=1).
The FDA announced on Nov. 1, 2018, that LivaNova USA Inc. is recalling the SORIN Heater-Cooler System 3T due to a chemical reaction that may render the disinfectant ineffective and a design flaw risking aerosol emissions. The agency classified the recall as Class II.
How to tell if you have it
Brand: LivaNova
Product: SORIN Heater-Cooler System 3T
REF: 16-02-85
Voltage: 120V~/60Hz
Serial numbers: 16S10958 thru 16S16847
The hazard
The firm stated that a chemical reaction may render the disinfectant/water preservative ineffective. Additionally, the recall addresses a design upgrade to reduce the risk of potential aerosol emissions from the device.
Context
GovInfoNow's records show LivaNova USA, Inc. has 18 other recalls on record since Jan. 24, 2018. Recent LivaNova recalls include a Jan. 3, 2025 notice for the SenTiva DUO VNS Therapy Generator regarding the risk of stopping therapy and a Dec. 12, 2024 notice for the SenTiva VNS Generator concerning stopped seizure control. Other recent recalls of similar products include the Philips Allura Xper FD10F Medical System recall (Dec. 15, 2025) and the Steris AMSCO 7052HP Washer/Disinfector recall (Nov. 19, 2025).
How to tell if you have this one
Check for the model number 3T with voltage specifications listed in the product description. Affected units include specific serial numbers ranging from 16S10027 to 16S16847 for the 120V/60Hz version.
Brand
LivaNova
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Identify the model number and voltage specifications on the device label to confirm if it's affected.
Contact Manufacturer
Reach out to LivaNova for guidance on the next steps if the device is confirmed affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including sate of PR and countries of Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0220-2020 (November 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0220-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.