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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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.
Recall announced
September 30, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
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) Verify model SL-2010M2096
- 3) Review listed lot numbers (e.g., A2500119, A2500121, etc)
- 4) Inspect packaging and labeling for matching identifiers
- 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
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Safety Guide
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