Use cautionMedical device recall · FDA · Published April 29, 2025
Fresenius 5008X HDF Blood Tubing Set Recall: Blood Leak Risk
Recall of 5008X HDF Hemodialysis Blood Tubing Sets with potential blood leaks during hemodialysis procedures. Affected models include 03-5100-7 and variants. Contact manufacturer for details.
Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
Take action
Contact the company
📍Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 920 · Waltham, MA 02451-1521
“Fresenius 5008X HDF Blood Tubing Set Recall: Blood Leak Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52369-fresenius-5008x-hdf-blood-tubing-set-recall-blood-leak-risk. Based on FDA recall #Z-1992-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1992-2025%22&limit=1).
The FDA announced on April 29, 2025, that Fresenius Medical Care Holdings, Inc. is recalling 5008X HDF Hemodialysis Blood Tubing Sets due to a potential blood leak hazard. The agency classified the recall as Class II and ongoing.
How to tell if you have it
Brand: Fresenius Medical Care
Product: 5008X Standard HDF Bloodline, Model Number: 03-5100-7
Product: 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C
Product: 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-2
Distribution: US Nationwide distribution in the state of Massachusetts
The hazard
The recall addresses the potential for blood leak occurring between the lower port of the venous chamber and the tubing. This hazard affects hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration procedures.
Context
GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since 2014-04-14. Other recent recalls of similar products include Fresenius Bicarby Dialysate Leaks Risk: Slip and Fall Hazard (2026-05-12), Fresenius 5008X Blood Tubing Set Recall: Risk of Online Port Errors (2026-05-11), and Fresenius Medical Care Bicarby Dialysate Recall: Incorrect Labeling Risk (2026-05-07). Additional similar product recalls include Fresenius Medical Care 5008X Blood Tubing Set Recall: Risk of Blood Leak During Treatment (2026-08-10), Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall: Blood Leak Risk (2026-08-10), and Fresenius Medical Care 5008X HD/HDF with Twister Tubing Set: Blood Leak Risk (2026-08-10).
How to tell if you have this one
Check for model numbers 03-5100-7, 03-5100-7C, or 03-5150-2 on the tubing set. The lot numbers 24LR01214, 24SR01010, 25ER01800 or similar variants are also indicators of affected units.
Brand
Fresenius Medical Care
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Model
Identify the model number on the tubing set, which may be 03-5100-7, 03-5100-7C, or 03-5150-2.
Contact Manufacturer
Reach out to Fresenius Medical Care for specific instructions on how to address the issue with the recalled tubing sets.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of Massachusetts.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 57 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1992-2025 (April 29, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1992-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.