Fresenius 5008X Blood Tubing Sets Recall
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Fresenius Medical Care Holdings, Inc. is recalling 113,544 units of 5008X Blood Tubing Sets due to potential online port errors from connection issues.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 9, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Fresenius Medical Care Holdings, Inc. initiated a voluntary recall due to the potential for Online Port Errors from connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
Which Products Are Affected
The recall covers 5008X Blood Tubing Set, 24 units per case, distributed nationwide in the United States to the states of AL, AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, PA, TX, VA. Affected model numbers include:
- 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6; UDI-DI: 00840861102556
- 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1; UDI-DI: 00840861102563
- 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3; UDI-DI: 00840861102518
- 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C; UDI-DI: 00840861102532
- 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8; UDI-DI: 00840861102525
Sets manufactured after February 26, 2026. Total: 113,544 units (4,731 cases). Recall number Z-2702-2026. Classification: Class II.
What You Should Do
The recall was initiated voluntarily by the firm via letter. No additional consumer action steps are specified in the recall data.
Why This Matters
This Class II recall affects over 113,000 units distributed across the United States, addressing a defect that could lead to connection issues during use.
Source
FDA recall Z-2702-2026, event ID 99061.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
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Similar body length
Nearest notices by article body length (1,524 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.