HIGH

B BRAUN MEDICAL Recalls Hemodialysis Bloodlines Over Air Bubble Risk

B BRAUN MEDICAL recalled 1,298,454 hemodialysis bloodlines on September 30, 2025. The recall results from the risk of micro-air bubbles due to damaged connectors. Patients should stop using the product immediately and follow the manufacturer’s instructions.

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

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

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Product Details

The recalled product is the Streamline Bloodline Set for Dialog, Model No. SL-2010M2096. The recall affects 1,298,454 units distributed nationwide in the U.S.

The Hazard

The recall addresses the potential for micro-air bubbles in the bloodline. These bubbles can cause air-in-line alarms, posing a serious risk to patient safety.

Reported Incidents

No specific incidents or injuries have been reported related to this recall, although the hazard level is classified as high.

What to Do

Patients and healthcare providers must stop using the device immediately. Contact B BRAUN MEDICAL INC or your healthcare provider for further instructions.

Contact Information

For further assistance, contact B BRAUN MEDICAL INC at their official website or through the recall notification letter.

Key Facts

  • Recall date: September 30, 2025
  • 1,298,454 units affected
  • Model No. SL-2010M2096
  • Risk of micro-air bubbles
  • Stop using immediately

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Safety Assessment

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

Product Classification

Product Details

Model Numbers
Model No. SL-2010M2096
UDI-DI 04046964367786
Lot Numbers: A2500119
A2500121
A2500128
+15 more
Affected States
ALL
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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