Liberty Select Cycler Software Version 2 — Class II medical device recall Z-0439-2021
Completed recall by Fresenius Medical Care Holdings, Inc., reported 2020-11-18, distributed nationwide. The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm durin
| Recall number | Z-0439-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2020-09-12 |
| Classified | 2020-11-07 |
| Reported by FDA | 2020-11-18 |
| Distributed | Nationwide (US) |
| Quantity | 9,907 devices |
| Model numbers | 180343, RTLR180343 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0439-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.