LivaNova 3T Heater Cooler System Recall: Incorrect Maintenance Labeling
LivaNova recalls 3T Heater Cooler Systems with incorrect maintenance labeling in Quick Reference Guides. Affected units may require correction to prevent improper maintenance.
Lower-risk recall
The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
Contact the company
What happened, in plain English
LivaNova is recalling specific models of 3T Heater Cooler Systems due to incorrect maintenance instructions in their Quick Reference Guides. This could lead to improper maintenance if users follow outdated schedules. Read more at govinfonow.com/recall/57545-livanova-3t-heater-cooler-system-recall-incorrect-maintenance-labeling.
Source Summary by GovInfoNow · govinfonow.com/recall/57545-livanova-3t-heater-cooler-system-recall-incorrect-maintenance-labeling · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0073-2024
Cite this page
“LivaNova 3T Heater Cooler System Recall: Incorrect Maintenance Labeling.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57545-livanova-3t-heater-cooler-system-recall-incorrect-maintenance-labeling. Based on FDA recall #Z-0073-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0073-2024%22&limit=1).
Why it’s dangerous
The Quick Reference Guide contains incorrect maintenance schedules, which could result in improper maintenance if users follow outdated instructions. This might lead to equipment malfunction but does not pose an immediate safety risk.
Who’s affected
Medical professionals using the 3T Heater Cooler System for patient care are most at risk. The recall affects specific serial numbers sold in the U.S. market.
How to tell if you have this one
Check for the model number 3T Heater Cooler System with serial numbers listed in the recall notice. The affected units have specific serial numbers starting with 20T31334 through 20T31553.
- Brand
LivaNova- Product
3T Heater Cooler System, REF: 16-02-85- Category
Medical device
What to do — step by step
Check Product Serial Number
Identify the serial number on your 3T Heater Cooler System to see if it matches the listed numbers in the recall.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 11 states.
FDA distribution: “US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN, NJ, CO, SC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Florida, Georgia, Indiana, Minnesota, New Jersey, North Carolina, South Carolina, Texas.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
How do I know if my unit is affected?
Check the serial number against the list of affected numbers provided in the recall notice.
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Where this comes from
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-0073-2024 (August 3, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0073-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.