Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 17, 2019
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
LivaNova USA Inc. recalled SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/… - a moderate-severity action.
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/… was recalled by LivaNova USA Inc. in April 17, 2019. Reason: For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).. Check the official notice for the remedy. Verify recall #Z-1099-2019 with the FDA Devices before acting.
The recall
LivaNova USA Inc. issued this moderate-severity FDA Devices recall-For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM)..
- Moderate
- severity level
- 6 units
- affected scope
- Class II
- classification
- April 17, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1099-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1099-2019) was formally reported on April 17, 2019, with the manufacturer initiating the action on September 14, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. LivaNova USA Inc. is listed as the recalling firm, operating out of Arvada, CO. Federal records list the affected scope as 6 devices.
The documented reason for this recall is: For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM). Distribution data in the federal record shows the product reached: US Distribution to states of: IN, MO, and OH.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
6 devices
Related Recalls
6
3 from same agency
Product description
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
Reason for recall
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1099-2019 |
| Date reported | April 17, 2019 |
| Date initiated | September 14, 2018 |
| Recalling firm | LivaNova USA Inc. |
| Firm location | Arvada, CO |
| Affected scope | 6 devices |
| Distribution | US Distribution to states of: IN, MO, and OH. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1099-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.. Recalled by LivaNova USA Inc.. Units affected: 6 devices.
Why was this product recalled? ▼
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 17, 2019. Severity: Moderate. Recall number: Z-1099-2019.
Where was the recalled product distributed? ▼
Distribution: US Distribution to states of: IN, MO, and OH..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1099-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 17, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.