Fresenius 5008X Blood Tubing Sets
Fresenius is recalling 5008X blood tubing sets due to potential connection errors between the tubing and the 5008X CAREsystem.
Stop using the affected blood tubing sets and contact your local Fresenius Medical Care representative for further instructions regarding replacement or return.
Why it was recalled
Fresenius Medical Care is recalling various 5008X blood tubing sets due to potential online port errors caused by connection issues between the tubing SafeLine and the 5008X CAREsystem substitution fluid port. These connection difficulties may lead to improper system performance during hemodialysis or hemodiafiltration procedures.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Model |
|---|---|
| 03-5110-6 | 03-5110-6 |
| 03-5160-1 | 03-5160-1 |
| 03-5300-3 | 03-5300-3 |
| 03-5300-3C | 03-5300-3C |
| 03-5350-8 | 03-5350-8 |
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Fresenius Medical Care Holdings, Inc.
Editorial summary by Recall Canary · last updated 2026-07-09 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification