FDA Early Alert · potentially high-risk device issue · B. Braun Medical Inc. · Last updated November 3, 2026

Is the B. Braun Streamline Bloodline Set for Dialog+ recalled?

Yes — certain Streamline Bloodline Set for Dialog+ devices. FDA's Early Alert notifies the public of a potentially high-risk device issue: B. Braun Medical Inc. issued a customer letter recommending removal of model SL-2010M2096 lots A2600099, A2600128, and A2600136 (UDI-DI 04046964367786; 04046964367779). A required solvent application step during assembly was not performed, so the dialyzer connector may have inadequate bonding and may detach or leak during priming or dialysis — with risk of blood loss, clotting/occlusion, treatment interruption, air ingress, and (extremely rarely) air embolism and death. As of October 10, 2026, the firm reported no serious injuries or deaths. Cease use, quarantine, and return affected product.

Last updated: November 3, 2026 · Primary: FDA Early Alert (CDRH news first visible ~Oct 27, 2026; FDA early-alerts list marks Nov 2, 2026). Related enforcement cross-check IDs only: Recall No. Z-1799-2026, Recall Event ID 98552 — not treated as this Early Alert's own number. Sales volume and distribution geography were not disclosed — this page does not invent them.

Framing

FDA Early Alert (potentially high-risk)

Product

Streamline Bloodline Set for Dialog+

Model

SL-2010M2096

Lots

A2600099, A2600128, A2600136

UDI-DI

04046964367786; 04046964367779

Injuries (as of Oct 10, 2026)

no serious injuries or deaths reported

Firm letter

Oct 20, 2026 — quarantine & return

Contact

[email protected] / (610) 849-1197

Identify product ↓ · Why it matters ↓ · What to do ↓

Which bloodlines are affected

Per the FDA Early Alert: B. Braun Medical Inc. recommended that certain hemodialysis bloodlines be removed from where they are used or sold.

1. Device use (FDA): blood tubing set indicated for hemodialysis with the Dialog+ Hemodialysis System.
2. The Early Alert page has no separate alert number. Related enforcement cross-check IDs only: Recall No. Z-1799-2026 and Recall Event ID 98552 — not used here as this Early Alert's own number, and no Class listing page is invented if one is missing on-site.
3. Sales volume and distribution geography were not disclosed — left blank on purpose.

Reason for the Early Alert

B. Braun stated that the required solvent application step during assembly was not performed, resulting in inadequate bonding of the dialyzer connector. 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 treatment, blood may be lost and treatment may need to be interrupted while the bloodline is replaced. Hemodialysis patients are medically fragile; extracorporeal blood loss may require clinical assessment, corrective treatment, professional medical intervention, or hospitalization. In severe cases, significant blood loss could be life-threatening.

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 and additional monitoring may be required. In extremely rare circumstances, air that passes the 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 (FDA).

This page is not medical advice. Follow facility protocols and the firm/FDA instructions.

What to do (firm letter Oct 20, 2026)

FDA summarizes B. Braun's October 20, 2026 customer letter:

1. Ensure all users in your organization and other concerned persons are informed about this recall.
2. If you are a distributor, forward the notice to your consignees.
3. Determine inventory of the affected items, cease use, and quarantine product subject to recall.
4. Return affected product to the manufacturer.

U.S. customers with adverse reactions, quality problems, or questions: [email protected] or (610) 849-1197. Health care professionals and consumers may also report problems to FDA MedWatch.

More: what to do with a recalled product · search FDA food/drug/device recalls · medication recalls hub

Date notes

• Firm customer letter dated October 20, 2026.
• Injury/death reporting cutoff on the Early Alert: as of October 10, 2026.
• CDRH news first visible about October 27, 2026; the FDA medical-device recalls and early-alerts list marks November 2, 2026. Official text does not disclose a separate revision date — both visibility dates are kept; no revision date is invented.

Not the StreamLine Long Version (Z-1801) air-bubble recall

Related but different model: a separate FDA enforcement template covers StreamLine Bloodline Long Version FMC, model SL-2000M2095L, Class I Z-1801-2026 (air-bubble issue). That is not this Early Alert. This page is only model SL-2010M2096 (inadequate dialyzer-connector bonding / solvent step).

Official sources

• FDA Early Alert: B. Braun Medical Inc. Removes Streamline Bloodline Set for Dialog+ (potentially high-risk device issue) — Checked: November 3, 2026
• FDA: Medical Device Recalls and Early Alerts list (list date mark Nov. 2, 2026 for this item) — Checked: November 3, 2026

Related enforcement IDs for cross-check only: Recall No. Z-1799-2026; Recall Event ID 98552. The Early Alert itself has no separate alert number. Quantity and geography stay blank until FDA discloses them.

Not affiliated with FDA or B. Braun Medical Inc.

FDA food and drug recall checker · Latest product recalls

FAQ