5008X Blood Tubing Set connection errors FDA Class II recall
Fresenius Medical Care is recalling 5008X Blood Tubing Sets due to potential online port errors that may occur when connecting the SafeLine to the substitution fluid port of the 5008X CAREsystem.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text identifies a potential connection issue but does not report any actual illnesses, injuries, or hospitalizations, making this a precautionary recall classified as Moderate per the rubric.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling the 5008X Blood Tubing Set, which is used in dialysis treatment. The recall affects five model variations (Model Numbers 03-5110-6, 03-5160-1, 03-5300-3, 03-5300-3C, and 03-5350-8) manufactured after February 26, 2026. A total of 113,544 units (4,731 cases) have been distributed nationwide.
The recall is due to a potential for online port errors caused by connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem. This is an FDA Class II recall.
The affected tubing sets were distributed in the following US states: AL, AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, PA, TX, and VA.
Patients and healthcare providers should contact Fresenius Medical Care for further instructions regarding the recalled product.
The recalled product
- Product
- 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. 3. 5008X HD/HDF…
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Sets manufactured after February 26
Distribution
Related recalls
Same manufacturer · Fresenius Medical Care Holdings, Inc.
See all →- HighBicarby dialysate bags carry an incorrect GTIN on the label
FDA (Devices) · 2026-06-17
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- HighDELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
FDA (Drugs) · 2026-05-13
- SevereDELFLEX Peritoneal Dialysis Solution Recall Due to Potential Sterility Issues
FDA (Drugs) · 2026-05-13
- HighDialysis machines recalled over software anomalies that may stop treatment
FDA (Devices) · 2025-12-24
Same hazard · connection error
See all →- SevereDraeger Medical Recalls VentStar Basic Breathing Circuits Due to Assembly Error
FDA (Devices) · 2019-01-30
- CriticalDraeger Medical Recalls VentStar Basic 250 Breathing Circuits Due to Assembly Error
FDA (Devices) · 2019-01-30
Similar recalls
- HighFresenius 5008X HDF Hemodialysis Blood Tubing Sets recalled for potential blood leaks
FDA (Devices) · 2025-06-25
- SevereFresenius Medical Care Recalls 5008X Standard HD Pre-Flush Blood Tubing Sets
FDA (Devices) · 2026-09-09
- SevereFresenius 5008X Blood Tubing Set Recalled for Potential Blood Leak
FDA (Devices) · 2026-09-09
- SevereFresenius 5008X HD/HDF Blood Tubing Set Recalled for Leak Risk
FDA (Devices) · 2026-09-09
- ModerateFresenius CombiSet Hemodialysis Blood Tubing Set Recalled for Handling Review
FDA (Devices) · 2026-09-30
- CriticalFDA Recalls Fresenius 2008T Hemodialysis Systems Due to PCBA Leaching
FDA (Devices) · 2023-10-18