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B BRAUN MEDICAL STREAMLINE BLOODLINE SET FOR DIALOG Recalled 1,298,454 Units (2025)

B BRAUN MEDICAL recalled 1,298,454 STREAMLINE BLOODLINE SET FOR DIALOG devices nationwide in the United States after observations of micro-air bubbles and air-in-line alarms linked to damaged arterial and venous connectors. The defect increases the risk of air entering the bloodstream during dialysis. Patients and healthcare providers should stop using this device immediately and follow the recall

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
September 30, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
September 30, 2025
Hazard Level
HIGH
Brand
B BRAUN MEDICAL
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
B BRAUN MEDICAL
Product type
Hemodialysis Bloodline Set
Model numbers
SL-2010M2096, UDI-DI 04046964367786
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    September 30, 2025

  2. Reported by FDA DEVICE

    October 29, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B BRAUN MEDICAL INC or your healthcare provider for instructions. Notification method: Letter

About This Product

Hemodialysis bloodlines connect a dialysis machine to a patient to filter blood. They are critical components in dialysis therapy.

Why This Is Dangerous

Damaged arterial and venous connectors can allow micro-air bubbles to enter the bloodstream. This can trigger air embolism risks and may trigger alarms to fail to protect the patient.

Industry Context

This recall is not described as part of a broader industry pattern.

Practical Guidance

How to identify if yours is affected

  1. 1) Verify model SL-2010M2096
  2. 3) Review listed lot numbers (e.g., A2500119, A2500121, etc)
  3. 4) Inspect packaging and labeling for matching identifiers
  4. 5) Stop using the device and contact the manufacturer for recall instructions

Where to find product info

Look on the device label for the model, UDI, and lot number. Official recall notices provide instructions and replacement options.

What timeline to expect

Manufacturers typically issue replacements or other remedies within 4-8 weeks after recall initiation.

If the manufacturer is unresponsive

  • Document all contact attempts with the manufacturer
  • Escalate to hospital risk management or regulatory authorities if needed
  • Consider legal counsel if no remedy is offered within a reasonable time

How to prevent similar issues

  • Verify supplier recalls before accepting components
  • Use only dialysis bloodlines approved for Dialog machines
  • Monitor for recall notices related to dialysis equipment

Documentation advice

Keep copy of recall notice, serial numbers, UDI, lot numbers, and all correspondence with the manufacturer.

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Product Details

Brand: B BRAUN MEDICAL Product: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 UDI-DI: 04046964367786 Lot Numbers: A2500119, A2500121, A2500128, A2500129, A2500130, A2500132, A2500133, A2500134, A2500149, A2500150, A2500151, A2500180, A2500181, A2500182, A2500185, A2500198, A2500199, A2500200 Quantity: 1,298,454 units Distribution: US Nationwide Distribution Sold From/To: Unknown Recall Date: 2025-09-30 Status: ACTIVE Price: Unknown Country of Origin: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Model SL-2010M2096
  • US nationwide distribution

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
SUFFOCATIONOTHER

Product Classification

Product Details

Model Numbers
SL-2010M2096
UDI-DI 04046964367786
Affected States
ALL
Report Date
October 29, 2025
Recall Status
ACTIVE

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