Streamline Bloodline Hemodialysis Sets Recalled for Patient Connector Defect
B. Braun is recalling 9,864,165 Streamline Bloodline Sets nationwide due to incomplete patient connector insertion. The defect may restrict fluid flow during hemodialysis and cause therapy delays.
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: This is a Class II medical device recall. The recalled hemodialysis bloodline sets pose a risk of occlusion and treatment delays due to incomplete connector insertion, but the source text does not report any illnesses, injuries, or hospitalizations. Per the rubric, risk-of-harm products without reported injury score at 3 (High).
Plain-English summary
B. Braun Medical Inc is recalling 9,864,165 units of Streamline Bloodline Sets for Dialog hemodialysis machines (model SL-2010M2096, all unexpired lot numbers) due to an insertion defect. This recall affects nationwide US distribution.
The patient connector may not fully insert into the Locksite, preventing the internal septum from opening fully enough. This incomplete insertion can restrict fluid flow during prograde rinseback procedures, which may cause delays in dialysis therapy. Clinicians may be forced to switch to retrograde flow methods to work around the problem.
This is a Class II medical device recall assigned recall number Z-3178-2024. As of the recall announcement, no illnesses or injuries have been reported in association with this defect.
The recalled product
- Product
- STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096
- Manufacturer
- B Braun Medical Inc
- Affected units
- 9,864,165
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 04046964367786
- 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 spinal epidural kits contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
Same hazard · occlusion
See all →- HighHalyard STANDARD LINE INSERTION PACK Recall for Silicone Seal Defect
FDA (Devices) · 2026-07-29
- HighIV set 490315 recalled over backflow between primary and secondary containers
FDA (Devices) · 2025-12-03
- HighIV set 490067 recalled over medication backflow between IV containers
FDA (Devices) · 2025-12-03
- HighIV set 490385 recalled over medication backflow between IV containers
FDA (Devices) · 2025-12-03
- HighIV set 490519 recalled over piggyback backflow and priming occlusion
FDA (Devices) · 2025-12-03
Similar recalls
- CriticalHemodialysis bloodline sets recalled over micro air bubbles from damaged connectors
FDA (Devices) · 2025-10-29
- CriticalB. Braun Hemodialysis Bloodlines Recalled Due to Potential Air Bubble Accumulation
FDA (Devices) · 2026-04-22
- SevereB. Braun StreamLine Dialog DR bloodlines may accumulate arterial air bubbles
FDA (Devices) · 2026-04-22
- 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
FDA (Devices) · 2016-05-11
- SevereB Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage Risk
FDA (Devices) · 2016-05-11