Fresenius Medical Care Renal Therapies Group recall: 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 and 3 more products
Fresenius Medical Care Renal Therapies Group, LLC is recalling 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 and 3 more products – 120 units; 62,544 units; 18,600; 6,624 units. The U.S. Food and Drug Administration published the recall on September 9, 2026; it began on August 10, 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 | 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 and 3 more products |
| Brand | Fresenius Medical Care Renal Therapies Group |
| Company | Fresenius Medical Care Renal Therapies Group, LLC |
| Type | Medical devices |
| Classification | Class II |
| Recall date | August 10, 2026 |
| Published by FDA | September 9, 2026 |
| Quantity | 120 units; 62,544 units; 18,600; 6,624 units |
| Recall ID | 99556 |
Recalled products (4)
- 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
- FDA recall number
- Z-3084-2026
- Codes, lots and dates
- Lots 25KR01227 25NR01257 UDI-DI 00840861102556
- Quantity
- 120 units
- Classification
- Class II
- 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
- FDA recall number
- Z-3085-2026
- Codes, lots and dates
- Lots 25JR01800 25KR01224 25LR01001 25NR01018 25NR01272 25PR01077 25PR01219 25PR01220 UDI-DI 00840861102518
- Quantity
- 62,544 units
- Classification
- Class II
- 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
- FDA recall number
- Z-3086-2026
- Codes, lots and dates
- Lots 25JR01801 25KR01225 25KR01251 25NR01016 25NR01265 UDI-DI 00840861102532
- Quantity
- 18,600
- Classification
- Class II
- 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
- FDA recall number
- Z-3087-2026
- Codes, lots and dates
- Lots 25JR01802 25NR01017 25NR01266 UDI-DI 00840861102525
- Quantity
- 6,624 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99556
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Waltham, MA, United States
Why it was recalled
The reason the FDA lists: “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.”
Where it was sold
Nationwide. Distribution as the FDA records it: “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.”
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 99556, 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 30, 2026 |  Fresenius Medical Care Renal Therapies Group recall: CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer ProtectorsMedical devices · 1743026 units | Communication to recommend reviewing the IFU and ensuring that all treatment preparation a… Serious | FDA Class II |
| 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 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 | Draeger recall: VentStar Resus NeoMedical devices · 1,063,643 units | Potential cracks in the hose, which could lead to leakage or the hose falling off. Most serious | FDA Class I |
| Oct 7, 2026 | Medline Industries recall: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories and 1 more productMedical devices · 771,127 total | a fire hazard Most serious | FDA Class I |
| Oct 7, 2026 | Karl Storz Endoscopy recall: HOPKINS Telescope 30¿Medical devices · 6 eyepieces | Due to incorrect inside packaging label for eyepiece. Serious | FDA Class II |
| Oct 7, 2026 | Noxbox recall: NOxBOXi Nitric Oxide Delivery SystemMedical devices · 1,667 units | Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxy… Serious | FDA Class II |
| 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 |
| Oct 7, 2026 | Tandem Diabetes Care recall: T:slim Mobile ApplicationMedical devices · 177 | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof… Serious | FDA Class II |
About this recall
Is Fresenius Medical Care Renal Therapies Group 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 recalled?
Yes. Fresenius Medical Care Renal Therapies Group, LLC recalled it on August 10, 2026; FDA published it September 9, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
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.
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.