FDAClass II · Medical device · Recall Z-3085-2026 · Recalled September 9, 2026

5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3 recall — Fresenius Medical Care Renal Therapies Group, LLC

Agency report date: September 9, 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 HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
Company / brand: Fresenius Medical Care Renal Therapies Group
Lot / serial / date codes: Lots 25JR01800 25KR01224 25LR01001 25NR01018 25NR01272 25PR01077 25PR01219 25PR01220 UDI-DI 00840861102518
Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania.

Agency product description and boundaries

5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3

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: Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.

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 HD/HDF Standard Blood Tubing Set Part Number 03-5300-3 recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-3085-2026
Brand: All Fresenius Medical Care Renal Therapies Group recalls
Classification: Class II
Units affected: 62,544 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3 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: Lots 25JR01800 25KR01224 25LR01001 25NR01018 25NR01272 25PR01077 25PR01219 25PR01220 UDI-DI 00840861102518
Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania.
Firm notified the public via: N/A
FDA event ID: 99556
Recall initiated: August 10, 2026
FDA classified: September 2, 2026
FDA report date: September 9, 2026

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Verify with the official sources:

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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 22, 2026 at 6:00 PM UTC.

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