Fresenius Medical Care Renal Therapies Group recall: CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors
Fresenius Medical Care Renal Therapies Group, LLC is recalling CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors – 1743026 units. The U.S. Food and Drug Administration published the recall on September 30, 2026; it began on July 29, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors |
| Brand | Fresenius Medical Care Renal Therapies Group |
| Company | Fresenius Medical Care Renal Therapies Group, LLC |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 29, 2026 |
| Published by FDA | September 30, 2026 |
| Quantity | 1743026 units |
| Recall ID | 99700 |
Recalled products
- CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;
- FDA recall number
- Z-3225-2026
- Codes, lots and dates
- Model Number: 03-2522-1; UDI-DI: 00840861102402 (Bag), 10840861102409 (Case); Lot codes: 26AR01010, 26BR01072, 26CR01067, 26DR01160, 26DR01198, 26AR01011, 26BR01074, 26CR01069, 26DR01161, 26DR01203, 26AR01034, 26BR01076, 26CR01070, 26DR01162, 26DR01206, 26AR01035, 26BR01077, 26CR01072, 26DR01163, 26DR01207, 26AR01046, 26BR01078, 26CR01073, 26DR01165, 26DR01209, 26AR01047, 26BR01079, 26CR01074, 26DR01166, 26DR01210, 26AR01056, 26BR01082, 26CR01075, 26DR01167, 26DR01255, 26AR01057, 26BR01083, 26CR01076, 26DR01168, 26ER01022, 26AR01058, 26BR01084, 26CR01079, 26DR01170, 26ER01023, 26AR01059, 26BR01085, 26CR01080, 26DR01171, 26ER01024, 26AR01230, 26BR01087, 26CR01081, 26DR01172, 26ER01029, 26BR01007, 26BR01088, 26CR01082, 26DR01173, 26ER01034, 26BR01035, 26BR01210, 26CR01083, 26DR01174, 26ER01035, 26BR01036, 26CR01014, 26CR01084, 26DR01175, 26ER01037, 26BR01037, 26CR01045, 26CR01085, 26DR01177, 26ER01039, 26BR01039, 26CR01046, 26CR01086, 26DR01180, 26ER01040, 26BR01045, 26CR01047, 26CR01087, 26DR01182, 26ER01042, 26BR01049, 26CR01048, 26CR01088, 26DR01183, 26ER01044, 26BR01051, 26CR01049, 26CR01090, 26DR01184, 26ER01048, 26BR01052, 26CR01051, 26CR01091, 26DR01185, 26ER01049, 26BR01053, 26CR01052, 26CR01092, 26DR01186, 26ER01054, 26BR01057, 26CR01054, 26CR01093, 26DR01187, 26ER01055, 26BR01058, 26CR01056, 26CR01094, 26DR01188, 26ER01056, 26BR01059, 26CR01057, 26CR01206, 26DR01189, 26ER01062, 26BR01060, 26CR01058, 26CR01207, 26DR01190, 26ER01065, 26BR01063, 26CR01059, 26CR01208, 26DR01191, 26ER01066, 26BR01064, 26CR01060, 26CR01209, 26DR01193, 26ER01074, 26BR01065, 26CR01061, 26CR01210, 26DR01194, 26ER01266, 26BR01066, 26CR01064, 26DR01013, 26DR01195, 26ER01268, 26BR01067, 26CR01065, 26DR01158, 26DR01196, 26ER01282, 26BR01069, 26CR01066, 26DR01159, 26DR01197;
- Quantity
- 1743026 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99700
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Waltham, MA, United States
Why it was recalled
The reason the FDA lists: “Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.”
Where it was sold
Nationwide. Distribution as the FDA records it: “Domestic: Nationwide Distribution;”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99700, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Fresenius Medical Care Renal Therapies Group recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Sep 9, 2026 |  Fresenius Medical Care Renal Therapies Group recall: GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B and 2 more productsMedical devices · 27,216 cs; 2,316 ea; 2,998 cs; 68 ea; 56,036 cs; 1,788 drums; 204 ea | Complaints of blue-green discoloration in product Serious | FDA Class II |
| Sep 9, 2026 | Fresenius Medical Care Renal Therapies Group recall: 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 and 3 more productsMedical devices · 120 units; 62,544 units; 18,600; 6,624 units | Heightened probability of blood leak from the connection between the Arterial Alpha Clip a… Serious | FDA Class II |
| Sep 2, 2026 | Fresenius Medical Care Renal Therapies Group recall: Fresenius Medical CareMedical devices · 1140 systems | Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regardi… Serious | FDA Class II |
All 4 Fresenius Medical Care Renal Therapies Group recalls →
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| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
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About this recall
Is Fresenius Medical Care Renal Therapies Group CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set recalled?
Yes. Fresenius Medical Care Renal Therapies Group, LLC recalled it on July 29, 2026; FDA published it September 30, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.