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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Diagnostic Equipment

B. Braun Hemodialysis Bloodlines Recalled for Air Bubble Risk

Agency Publication Date: April 15, 2026
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Summary

B. Braun Medical Inc. is recalling over 7.3 million Hemodialysis Bloodlines, including StreamLine and Low Volume models, due to the potential for small air bubbles to accumulate in the arterial lines during use. This issue occurs because blood gases can adhere to the tubing under negative pressure. The recall affects millions of units manufactured throughout mid-2025 and distributed to medical facilities across the United States and Canada.

Risk

Air bubbles in the bloodline can lead to an air embolism, a life-threatening condition where air enters the patient's bloodstream and blocks blood flow to vital organs. While no injuries have been reported, the defect poses a critical risk during dialysis treatments.

What You Should Do

  1. Check the model numbers on your hemodialysis bloodline sets to see if you have affected products: SL-2010M2096A, SL-2010M2096, SL-2000M2095DA, SL-2000M2095L, B3-3632M3705, or B3-4630M4705.
  2. Identify the manufacturing date or lot information on the packaging; all lots manufactured since late May to August 2025 (depending on the specific model) are included. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR.
Model / REF:
SL-2010M2096A
UDI:
04046955674992
04046955735280
Date Ranges: All lots manufactured since 09JUN2025

Recall Number: Z-1798-2026; Distributed quantity: 3,158,104 units

Product: B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG
Model / REF:
SL-2010M2096
UDI:
04046964367786
04046964367779
Date Ranges: All lots manufactured since 25MAY2025

Recall Number: Z-1799-2026; Distributed quantity: 2,653,711 units

Product: B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA
Model / REF:
SL-2000M2095DA
UDI:
04046955776023
04046955776016
Date Ranges: All lots manufactured since 09JUN2025

Recall Number: Z-1800-2026; Distributed quantity: 1,174,271 units

Product: B. Braun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC
Model / REF:
SL-2000M2095L
UDI:
04046955348909
04046955348893
Date Ranges: All lots manufactured since 29JUN2025

Recall Number: Z-1801-2026; Distributed quantity: 328,640 units

Product: B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT
Model / REF:
B3-3632M3705
UDI:
04046955348824
04046955348817
Date Ranges: All lots manufactured since 01AUG2025

Recall Number: Z-1802-2026; Distributed quantity: 4,848 units

Product: B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT
Model / REF:
B3-4630M4705
UDI:
04046955348848
04046955348831
Date Ranges: All lots manufactured since 05AUG2025

Recall Number: Z-1803-2026; Distributed quantity: 4,884 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98552
Status: Active
Manufacturer: B Braun Medical Inc
Sold By: Medical distributors; Dialysis centers
Manufactured In: United States
Units Affected: 7,324,458
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.