Fresh Recalls

5008X Blood Tubing Set: recall status

Notice names this product. Fresenius Medical Care Holdings’s 5008X Blood Tubing Set is named in FDA Class II recall Z-2702-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported 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. Identifying details: 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.. Units affected: 113,544 units (4,731 cases). Status: Ongoing.

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.

Brand
Fresenius Medical Care Holdings

Recalls naming this model

FDA Class II · Medical device · July 15, 2026

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

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.

Company / brand: Fresenius Medical Care Holdings recalls

Affected product: 5008X Blood Tubing Set recall status

Official ID Z-2702-2026 · Official record ↗

See all Fresenius Medical Care Holdings recalls →

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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.