B Braun Streamline Bloodline Set Recalled for Potential Occlusion
B Braun Medical Inc. is recalling Streamline Bloodline Sets because incomplete connector insertion may cause flow restrictions during hemodialysis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect could lead to flow restrictions and therapy delays, representing a risk of harm without reported injuries, which aligns with the High severity criteria.
Plain-English summary
B Braun Medical Inc. is recalling Streamline Bloodline Sets for Dialog DR, model SL-2010M2096A, used to transfer blood between a patient and a hemodialyzer during hemodialysis. The recall involves 1,126,211 units distributed nationwide in the United States. All unexpired lot numbers are affected.
The recall is due to a potential design issue where the patient connector may not insert fully into the Locksite. If this occurs, the internal septum may not open completely, which can restrict blood flow during prograde rinseback procedures. This may cause delays in therapy and require clinicians to switch to a retrograde flow method.
Healthcare facilities and patients should check their inventory for this specific model and contact B Braun Medical Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096A
- Manufacturer
- B Braun Medical Inc
- Category
- Medical Device — Hemodialysis
- Affected units
- 11,262,112
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI 04046955674992
- All Unexpired Lot Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by B Braun Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · B Braun Medical Inc
See all →- CriticalB. Braun Recalls Sodium Chloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-16
- LowB Braun Recalls Discofix Stopcock Sets Due to Incorrect Expiration Date
FDA (Devices) · 2026-09-09
- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- ModerateB. Braun UPMC double catheter trays contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun kits contain Mastisol adhesive with potentially cracking tubing
FDA (Devices) · 2026-06-10
Same hazard · flow restriction
See all →- HighBaxter Exacta Mix inlet sets may contain incorrect 0.8-micron filters
FDA (Devices) · 2026-06-10
- HighHemodialysis bloodline connector insertion defect may cause flow restriction
FDA (Devices) · 2024-09-25
- HighStreamline Bloodline Hemodialysis Sets Recalled for Patient Connector Defect
FDA (Devices) · 2024-09-25
- HighHemodialysis Bloodline Tubing Recall Over Incomplete Connector Insertion Risk
FDA (Devices) · 2024-09-25
- HighBD Alaris Infusion Pump Buerette Set Connector Valve Occlusion Issues
FDA (Devices) · 2021-09-22
Similar recalls
- SevereB. Braun StreamLine Dialog DR bloodlines may accumulate arterial air bubbles
FDA (Devices) · 2026-04-22
- CriticalB. Braun Hemodialysis Bloodlines Recalled Due to Potential Air Bubble Accumulation
FDA (Devices) · 2026-04-22
- CriticalHemodialysis bloodline sets recalled over micro air bubbles from damaged connectors
FDA (Devices) · 2025-10-29
- SevereB. Braun StreamLine long bloodlines may accumulate arterial air bubbles
FDA (Devices) · 2026-04-22
- SevereB Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage Risk
FDA (Devices) · 2016-05-11
- SevereB Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage
FDA (Devices) · 2016-05-11