--- title: B. Braun Medical Inc. Recalls Streamline Bloodline Set for Dialog+ canonical: https://federalfeed.com/b-braun-medical-inc-recalls-streamline-bloodline-set-for-dialog/ published: '2026-11-02T15:10:33-05:00' updated: '2026-11-02T15:10:33-05:00' author: FederalFeed Staff section: Recalls tags: - FDA - Medical Devices source: Food and Drug Administration source_url: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-b-braun-medical-inc-removes-streamline-bloodline-set-dialog publisher: FederalFeed attribution: Copyright FederalFeed. Quote with credit to FederalFeed and a link to the canonical URL above. --- # B. Braun Medical Inc. Recalls Streamline Bloodline Set for Dialog+ On November 1, 2026, the Food and Drug Administration issued an Early Alert regarding a recall of the Streamline Bloodline Set for Dialog+ by B. Braun Medical Inc. The company recommended that affected customers remove certain Hemodialysis Bloodlines from use due to a potential high-risk device issue, which could lead to serious complications during dialysis treatment. The recall affects specific models and lots, and B. Braun Medical Inc. has advised customers to inform users, quarantine the affected devices, and return them to the manufacturer. --- ### Press Release: Food and Drug Administration *Published November 1, 2026. Reproduced in full from the [Food and Drug Administration](http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-b-braun-medical-inc-removes-streamline-bloodline-set-dialog).* #### Early Alert: B. Braun Medical Inc. Removes Streamline Bloodline Set for Dialog+ ***CDRH is issuing this*** [***Early Alert***](http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/what-early-alert) ***to notify the public of a potentially high-risk device issue.** The FDA will keep the public informed and update this web page as significant new information becomes available.* #### Affected Product The FDA is aware that B. Braun Medical Inc. has issued a letter to affected customers recommending certain Hemodialysis Bloodlines be removed from where they are used or sold. - Product Description: Streamline Bloodline Set for Dialog+ - Model: SL-2010M2096 - UDI-DI: 04046964367786; 04046964367779 - Impacted Lots: A2600099, A2600128, A2600136 #### What to Do Ensure all users are informed of the recall. Identify and quarantine all affected devices. On October 20, 2026, B. Braun Medical Inc. sent all affected customers a letter recommending the following actions: - Ensure all users in your organization and other concerned persons are informed about this recall. - If you are a distributor, please forward this notice to your consignees. - Determine inventory of the affected items, cease use and quarantine product subject to recall. Return affected product to the manufacturer. Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available. #### Reason for Alert B. Braun Medical Inc. stated that the required solvent application step during assembly was not performed, resulting in inadequate bonding of the dialyzer connector. As a result, the bloodline connector may detach or leak during priming or dialysis treatment, potentially leading to blood loss, clotting and occlusion of the extracorporeal circuit, and/or air ingress into the blood circuit. If the arterial tubing detaches, partially separates, or leaks during dialysis treatment, blood may be lost from the extracorporeal circuit, and the treatment may need to be interrupted while the bloodline is replaced. In some cases, blood loss may also occur due to clotting and occlusion of the bloodline, requiring replacement of the extracorporeal circuit. Hemodialysis patients are medically fragile, and extracorporeal blood loss may require clinical assessment, corrective treatment, professional medical intervention, or hospitalization. In severe cases, significant blood loss could be life-threatening. Inadequate bonding may also result in leakage or partial separation of the arterial tubing connection, permitting air entry into the blood circuit. Air entering the blood circuit is expected to be detected by the dialysis machine's air detection system and managed by healthcare personnel; however, treatment interruption, bloodline replacement, additional patient assessment and monitoring, and medical intervention may be required. In extremely rare circumstances, air that passes the dialysis machine air detection system could result in air embolism and death. As of October 10, 2026, B. Braun Medical Inc. has reported no serious injuries or deaths associated with this issue. #### Device Use The Streamline Bloodline Set for Dialog+ Hemodialysis System is a blood tubing set indicated for hemodialysis. #### Contact Information Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact B. Braun Medical Inc. at [recalls@bbraunusa.com](mailto:recalls@bbraunusa.com) or (610) 849-1197. #### Unique Device Identifier (UDI) The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly. - [How do I recognize a UDI on a label?](http://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics) - [AccessGUDID database, Identify Your Medical Device](https://accessgudid.nlm.nih.gov/) - [Benefits of a UDI System](http://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/benefits-udi-system) #### How do I report a problem? Health care professionals and consumers may [report adverse reactions or quality problems](https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Source: [Food and Drug Administration](http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-b-braun-medical-inc-removes-streamline-bloodline-set-dialog)