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The FDA issued an Early Alert after B. Braun advised affected customers to stop using and return three lots of Streamline Bloodline Set for Dialog+. The company said a missed solvent-application step may leave the dialyzer connector inadequately bonded, creating risks including blood loss and air entering the blood circuit. As of October 10, 2026, B. Braun had reported no serious injuries or deaths associated with the issue.
The U.S. Food and Drug Administration has issued an Early Alert for three lots of B. Braun’s Streamline Bloodline Set for Dialog+, saying the company advised affected customers to stop using the products, quarantine them and return them. B. Braun attributed the issue to a missed solvent-application step that may leave a bloodline connector inadequately bonded, creating potential risks during hemodialysis.
The affected product is the Streamline Bloodline Set for Dialog+, model SL-2010M2096. The FDA lists UDI-DI numbers 04046964367786 and 04046964367779 and identifies lots A2600099, A2600128 and A2600136. The set is blood tubing used with the Dialog+ hemodialysis system.
According to the FDA’s summary of B. Braun’s explanation, the required solvent application during assembly was not performed. The company said this could result in inadequate bonding of the dialyzer connector. A connector could then detach, partially separate or leak during priming or dialysis treatment, potentially causing blood loss, clotting or blockage of the extracorporeal circuit, or allowing air to enter the blood circuit.
The customer actions described by the FDA are to notify users and other relevant parties, check inventory, cease use, quarantine affected product and return it to the manufacturer. Distributors are asked to forward the notice to their customers. The FDA says it is reviewing information about the issue and will update its alert as significant new information becomes available.
Risks During Hemodialysis Treatment
The alert concerns tubing that carries blood through an extracorporeal circuit during hemodialysis. If a connector leaks or separates, the FDA says treatment may have to be interrupted while staff replace the bloodline. Blood loss could require clinical assessment, corrective treatment or hospitalization, particularly because hemodialysis patients may be medically fragile. Clotting or circuit occlusion could also require replacement of the extracorporeal circuit.
The FDA also describes a possible route for air to enter the blood circuit. It says the dialysis machine’s air-detection system is expected to detect and help manage air, with healthcare personnel responding as needed. However, treatment interruption, replacement of the bloodline, additional monitoring or medical intervention may still be required. The agency says that, in extremely rare circumstances, air passing the detection system could cause an air embolism and death.
Those are potential outcomes identified in the alert, not reported events tied to these lots. B. Braun had reported no serious injuries or deaths associated with the issue as of October 10, 2026, according to the FDA. The advisory matters because facilities and distributors need to identify the specified lots and keep them out of use while the agency reviews the matter.
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Affected Lots and Customer Notice
The FDA’s Early Alert says B. Braun sent a letter to affected customers on October 20, 2026, recommending that the specified bloodlines be removed from places where they are used or sold. The FDA presents the alert as notice of a potentially high-risk device issue and says it will keep the public informed as significant information becomes available.
The scope described in the alert is limited to the product, model, UDI-DI numbers and three lot numbers listed above. The source material does not say that every Streamline Bloodline Set or every Dialog+ system is affected. Users and distributors are directed to check their inventory against the listed identifiers rather than assume that all products in the range are included.
The FDA says healthcare professionals and consumers can report adverse reactions or product-quality problems through MedWatch, its safety information and adverse-event reporting program. U.S. customers with questions or concerns about the recall can contact B. Braun at recalls@bbraunusa.com or (610) 849-1197.
“The required solvent application step during assembly was not performed, resulting in inadequate bonding of the dialyzer connector.”
— B. Braun, as described in the FDA alert
Open Questions in the FDA Review
The alert does not give the number of affected units distributed, identify how many remain in use, or describe the full geographic distribution of the listed lots. It also does not provide a completion date for the return process or say whether additional lots or products could be included later.
As of the date specified in the alert, October 10, 2026, B. Braun had reported no serious injuries or deaths associated with the issue. That statement is time-specific; the FDA says its review is continuing and may update the page when significant new information is available. The source does not report confirmed cases of connector separation, blood loss or air entry associated with the affected lots.
The alert describes the possible hazards and expected machine safeguards, but it does not provide a rate or likelihood for connector failure, blood loss or air entering the circuit. Those risks should not be read as evidence that an event has occurred in every affected device or that the air-detection system will fail in routine use.
Customer Actions and FDA Updates
Facilities and distributors should follow the actions in B. Braun’s customer letter as summarized by the FDA: inform relevant users, identify stock by product and lot number, stop using the affected devices, quarantine them and arrange their return to the manufacturer. Distributors should pass the notice to their consignees. The alert directs readers to check the FDA page for updates.
Healthcare professionals and consumers who experience an adverse reaction or quality problem can file a report through FDA MedWatch. U.S. customers seeking recall assistance can contact B. Braun by email at recalls@bbraunusa.com or by phone at (610) 849-1197. The FDA has not provided a date for completing its review or announced any further action in the supplied alert.
Key Questions
Which B. Braun bloodline sets are affected?
The FDA lists Streamline Bloodline Set for Dialog+, model SL-2010M2096, in lots A2600099, A2600128 and A2600136. The alert also lists UDI-DI numbers 04046964367786 and 04046964367779.
What should a facility do with the affected products?
The FDA says customers should notify relevant users, check inventory, stop using and quarantine affected devices, and return them to B. Braun. Distributors should forward the notice to their customers.
Why is B. Braun removing these lots?
B. Braun told the FDA that a required solvent-application step was missed during assembly, which may cause inadequate bonding at the dialyzer connector. A connector could detach or leak during priming or treatment.
Have injuries or deaths been reported?
According to the FDA, B. Braun reported no serious injuries or deaths as of October 10, 2026. The alert describes potential risks; it does not report that those outcomes occurred in connection with the affected lots.
Where can customers ask questions or report a problem?
U.S. customers can contact B. Braun at recalls@bbraunusa.com or (610) 849-1197. Healthcare professionals and consumers can report adverse reactions or quality problems through the FDA’s MedWatch program.
Source: fda.gov
