FDA Devices recall · Reported November 18, 2020
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more flui…
Fresenius Medical Care Holdings, Inc. recalled Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343 - a moderate-severity action.
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343 was recalled by Fresenius Medical Care Holdings, Inc. in November 18, 2020. Reason: The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm duri…. Check the official notice for the remedy. Verify recall #Z-0439-2021 with the FDA Devices before acting.
The recall
Fresenius Medical Care Holdings, Inc. issued this moderate-severity FDA Devices recall-The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm duri….
- Moderate
- severity level
- 10K units
- affected scope
- Class II
- classification
- November 18, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0439-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Reason for recall
The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may lead to inadequate dialysis which could result in the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Completed |
| Recall number | Z-0439-2021 |
| Date reported | November 18, 2020 |
| Date initiated | September 12, 2020 |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Firm location | Waltham, MA |
| Affected scope | 9,907 devices |
| Distribution | Distributed nationwide throughout the U.S and Puerto Rico. 9,907 devices currently in the field. 361 devices have been deactivated. 4,870 devices are ready to be shipped to customers along with the Urgent Medical Device Correction notic… |
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-0439-2021) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026