5008X HD/HDF with CLiC Blood recallZ-3086-2026 · Fresenius Medical Care Renal Therapies Group, LLC · initiated Aug 10, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Medical Care Renal Therapies Group, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Component change control
What the company is doing
On 8/10/2026, the firm began notifying consignees via URGENT MEDICAL DEVICE RECALL letters. Customers were instructed to 1. Identify any affected product on hand. 2. IMMEDIATELY segregate and discontinue use of affected lot. 3. Contact the call center at 1-888-943-4901 and reference Event 8514, between 8:00 AM 4:30 PM Eastern daily, for return of affected lots and replacement of your stock. 4, Complete and return the included reply form.
Recall details
- Recall number
- Z-3086-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 10, 2026
- Posted by the FDA
- Sep 2, 2026
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Quantity
- 18,600
- Product code
- KOC
- FDA submissions
- K243505
- 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.
Product description
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Code information (models, lots, serial numbers)
Lots 25JR01801 25KR01225 25KR01251 25NR01016 25NR01265 UDI-DI 00840861102532
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- 5008X 03-5300-3CFresenius Medical Care Renal Therapies Group, LLC · Set, Tubing, Blood, With And Without Anti-Regurgitation Valve2 recalls6 reports
Other devices under the same FDA submission
4 devices cleared under K243505 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- 5008X 03-5300-3Fresenius Medical Care Renal Therapies Group, LLC · Set, Tubing, Blood, With And Without Anti-Regurgitation Valve2 recalls23 reports
- 5008X 03-5350-8Fresenius Medical Care Renal Therapies Group, LLC · Set, Tubing, Blood, With And Without Anti-Regurgitation Valve2 recalls0 reports
- 5008X 03-5110-6Fresenius Medical Care Renal Therapies Group, LLC · Set, Tubing, Blood, With And Without Anti-Regurgitation Valve2 recalls0 reports
- 5008X 04-3000-9Fresenius Medical Care Renal Therapies Group, LLC · Set, Tubing, Blood, With And Without Anti-Regurgitation Valve1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 99556).
- Z-3084-2026 · Open, Classified5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
- Z-3085-2026 · Open, Classified5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
- Z-3087-2026 · Open, Classified5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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