FDAClass II · Medical device · Recall Z-2702-2026 · Recalled July 15, 2026

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

Agency report date: July 15, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: 5008X Blood Tubing Set
Company / brand: Fresenius Medical Care Holdings
Lot / serial / date codes: Sets manufactured after February 26, 2026 1. Model Number: 03-5110-6; UDI-DI: 00840861102556; Lot Number: 26BR01177. 2. Model Number: 03-5300-3; UDI-DI: 00840861102518; Lot Numbers: 26BR01184, 26BR01202, 26CR01025, 26CR01039, 26CR01803, 26BR01185, 26BR01214, 26CR01026, 26CR01040, 26CR01804, 26BR01188, 26BR01215, 26CR01027, 26CR01041, 26DR01134, 26BR01189, 26BR01805, 26CR01029, 26CR01043, 26BR01201, 26CR01003, 26CR01034, 26CR01800. 3. Model Number: 03-5300-3C; UDI-DI: 00840861102532; Lot Numbers: 26CR01018, 26CR01020, 26DR01129, 26DR01150, 26CR01019, 26CR01021, 26DR01130, 26DR01151. 4. Model Number: 03-5350-8; UDI-DI: 00840861102525; Lot Numbers: 26CR01017, 26DR01077, 26DR01079, 26DR01080.
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.

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

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

Affected product: 5008X Blood Tubing Set recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

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

Affected products

5008X Blood Tubing Set recall status

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; Lot Number: 26BR01177. 2. Model Number: 03-5300-3; UDI-DI: 00840861102518; Lot Numbers: 26BR01184, 26BR01202, 26CR01025, 26CR01039, 26CR01803, 26BR01185, 26BR01214, 26CR01026, 26CR01040, 26CR01804, 26BR01188, 26BR01215, 26CR01027, 26CR01041, 26DR01134, 26BR01189, 26BR01805, 26CR01029, 26CR01043, 26BR01201, 26CR01003, 26CR01034, 26CR01800. 3. Model Number: 03-5300-3C; UDI-DI: 00840861102532; Lot Numbers: 26CR01018, 26CR01020, 26DR01129, 26DR01150, 26CR01019, 26CR01021, 26DR01130, 26DR01151. 4. Model Number: 03-5350-8; UDI-DI: 00840861102525; Lot Numbers: 26CR01017, 26DR01077, 26DR01079, 26DR01080.
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

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Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 13, 2026 at 6:00 PM UTC.

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