FDAClass II · Medical device · Recalled July 15, 2026

5008X Blood Tubing Set recall — Fresenius Medical Care Holdings, Inc.

Hazard: Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2702-2026
Brand: Fresenius Medical Care Holdings
Classification: Class II
Units affected: 113,544 units (4,731 cases)
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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 Standard Blood Tubing Set; Model Number: 03-5300-3. 4. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 5. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.

Affected products

5008X Blood Tubing Set

Companies & origin

Recalling firm location: Waltham, MA, United States
Firm address: 920 Winter St Bld 920, N/A, 02451-1521

Identifying details (verbatim from the notice)

Product codes / lots: Sets manufactured after February 26, 2026 1. Model Number: 03-5110-6. UDI-DI: 00840861102556. 2. Model Number: 03-5160-1. UDI-DI: 00840861102563. 3. Model Number: 03-5300-3. UDI-DI: 00840861102518. 4. Model Number: 03-5300-3C. UDI-DI: 00840861102532. 5. Model Number: 03-5350-8. UDI-DI: 00840861102525.
Distribution: US Nationwide distribution in 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.
Firm notified the public via: Letter
FDA event ID: 99061
Recall initiated: May 11, 2026
FDA classified: July 8, 2026
FDA report date: July 15, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 9:00 PM UTC.

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