Use cautionMedical device recall · FDA · Published May 11, 2026
Fresenius 5008X Blood Tubing Set Recall: Risk of Online Port Errors
Fresenius Medical Care recalls 5008X Blood Tubing Sets with potential online port errors when connecting SafeLine to substitution fluid port. Affected units include specific model numbers and lots manufactured after February 26, 2026.
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.
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Contact the company
📍Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 920 · Waltham, MA 02451-1521
✎ GovInfoNow plain-language explainer
Fresenius Medical Care is recalling 5008X Blood Tubing Sets that may cause online port errors when connecting the SafeLine to the substitution fluid port. This could lead to incorrect blood flow measurements during dialysis treatments. Affected units have specific model numbers and were manufactured after February 26, 2026. Read more at govinfonow.com/recall/49190-fresenius-5008x-blood-tubing-set-recall-risk-of-online-port.
“Fresenius 5008X Blood Tubing Set Recall: Risk of Online Port Errors.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/49190-fresenius-5008x-blood-tubing-set-recall-risk-of-online-port. Based on FDA recall #Z-2702-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2702-2026%22&limit=1).
Fresenius Medical Care Holdings, Inc. recalled 5008X Blood Tubing Sets due to potential online port errors from connection issues, according to the FDA on May 11, 2026.
How to tell if you have it
Brand: Fresenius Medical Care
Product: 5008X Blood Tubing Set
Model Number: 03-5110-6
Model Number: 03-5300-3
Model Number: 03-5300-3C
Model Number: 03-5350-8
Units affected: 113,544 units (4,731 cases)
The hazard
The recall addresses potential online port errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem, according to the FDA.
Context
GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since April 14, 2014. Other recent recalls include a May 12, 2026 notice for Bicarby Dialysate leaks and a May 7, 2026 notice for incorrect labeling of the same product. Additional similar products recalled by Fresenius on April 6, 2026, involved DELFLEX Dialysis Bags due to sterility risks.
How to tell if you have this one
Check for model numbers 03-5110-6, 03-5300-3, 03-5300-3C, or 03-5350-8 on the tubing set. Units manufactured after February 26, 2026 are affected. The lot numbers listed in the recall notice are also specific to 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 to determine if it is affected (03-5110-6, 03-5300-3, 03-5300-3C, or 03-5350-8).
Verify Manufacturing Date
Ensure the tubing set was manufactured after February 26, 2026 to confirm it is part of the recall.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 23 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Texas, Virginia.
Recall timeline
FDA published this recall 2 months 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-2702-2026 (May 11, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2702-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 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.