FDA recall, , High risk
B. Braun Hemodialysis Bloodlines
B. Braun Hemodialysis Bloodlines may accumulate small air bubbles in the arterial line.
Summary by Recall Canary from the FDA notice
What happened
B. Braun Medical Inc of Bethlehem, Pennsylvania recalled several hemodialysis bloodlines because blood gases may adhere to the tubing under negative pressure, allowing small air bubbles to accumulate in the arterial line.
The products include the Barun Hemodialysis Bloodlines StreamLine Bloodline Long Version, Braun Hemodialysis Bloodlines STREAMLINE BLOODLINE SET FOR DIALOG DR, STREAMLINE FRESENIUS FOR DAVITA, LOW VOL NO CHAMBER 2.6MM PUMP SEGMENT, STREAMLINE BLOODLINE SET FOR DIALOG, and LOW VOL NO CHAMBER 4.8MM PUMP SEGMENT.
The company began the recall on March 19, 2026, and the FDA added it to its Enforcement Report on April 15, 2026. The products were distributed nationwide in the US and in Canada.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your set affected?
6 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
B. Braun Hemodialysis Bloodlines, Streamline Bloodline Set for Dialog DR.
- Model
- SL-2010M2096A
- UDI-DI
- 04046955674992
- 04046955735280
- Lot code
- All lots manufactured since 09JUN2025
B. Braun Hemodialysis Bloodlines, Streamline Bloodline Set for Dialog.
- Model
- SL-2010M2096
- UDI-DI
- 04046964367786
- 04046964367779
- Model code
- SL-2010M2096
- Lot code
- All lots manufactured since 25MAY2025.
Some entries omit identifying details. Check the notice to confirm which units are affected.
B. Braun Hemodialysis Bloodlines, Streamline Fresenius for Davita.
- Model
- SL-2000M2095DA
- UDI-DI
- 04046955776023
- 04046955776016
- Lot code
- All lots manufactured since 09JUN2025.
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC.
- Model
- SL-2000M2095L
- UDI-DI
- 04046955348909
- 04046955348893
- Lot code
- All lots manufactured since 29JUN2025.
B. Braun Hemodialysis Bloodlines, Low VOL, No Chamber 2.6MM Pump Segment.
- Model
- B3-3632M3705
- UDI-DI
- 04046955348824
- 04046955348817
- Lot code
- All lots manufactured since 01AUG2025.
B Braun Hemodialysis Bloodlines, Low VOL, No Chamber 4.8MM Pump Segment.
- Model
- B3-4630M4705
- UDI-DI
- 04046955348848
- 04046955348831
- Lot code
- All lots manufactured since 05AUG2025.
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the country of Canada.
- Company
- B Braun Medical IncBethlehem, Pennsylvania
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98552
- Recall numbers
- Z-1798-2026 to Z-1803-2026
All recalls from B Braun Medical Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
