LivaNova SORIN Heater-Cooler System 3T Recall: NTM Contamination Risk
LivaNova recalls six units of SORIN Heater-Cooler System 3T (REF 16-02-85) due to post-deep cleaning water testing positive for nontuberculous mycobacteria. Affected units have specific serial numbers.
Lower-risk recall
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
Contact the company
What happened, in plain English
LivaNova is recalling six units of the SORIN Heater-Cooler System 3T (REF 16-02-85) because water samples after deep cleaning tested positive for nontuberculous mycobacteria. This could pose a health risk if the system is used in medical procedures. Read more at govinfonow.com/recall/69858-livanova-sorin-heater-cooler-system-3t-recall-ntm-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/69858-livanova-sorin-heater-cooler-system-3t-recall-ntm-contamination-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1099-2019
Cite this page
“LivaNova SORIN Heater-Cooler System 3T Recall: NTM Contamination Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69858-livanova-sorin-heater-cooler-system-3t-recall-ntm-contamination-risk. Based on FDA recall #Z-1099-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1099-2019%22&limit=1).
Why it’s dangerous
The water sample tested positive for nontuberculous mycobacteria after deep cleaning. This type of bacteria can cause infections in medical settings, though the risk is low for most users.
Who’s affected
Patients using the SORIN Heater-Cooler System 3T with a Stockert/Sorin heart-lung machine may be affected. Medical staff handling these units are most at risk.
How to tell if you have this one
Check for serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877 on the unit. The product is intended for use with specific heart-lung machines.
- Brand
LivaNova- Category
Medical device
What to do — step by step
Check Serial Numbers
Look for the specific serial numbers listed: 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “US Distribution to states of: IN, MO, and OH.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Indiana, Missouri, Ohio.
Recall timeline
FDA terminated this recall 4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have one of these units?
Check the serial number against the list provided. If it matches, contact LivaNova for further instructions.
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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-1099-2019 (September 14, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1099-2019 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.