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FDA · Medical devicesClass I

B Braun Medical Inc medical device recall: Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE…

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
97609
Recall initiated
Sep 30, 2025
Classified by FDA
Oct 22, 2025
Posted in Enforcement Report
Oct 29, 2025
Recalling firm
B BRAUN MEDICAL INC
Firm location
Allentown, PA, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Letter
Products in this event
1

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

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

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Sep 30, 2025. FDA classified it 22 days later, on Oct 22, 2025. Distribution reported by FDA: Domestic: US Nationwide Distribution. B BRAUN MEDICAL INC has 91 recalls in our records.

Recalled products (1)

  • Z-0070-2026 Class I Ongoing

    Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A

    Codes / lots: Model No. 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, A2500203, A2500204, A2500205, A2500206, A2500207, A2500208, A2500209, A2500210, A2500211, A2500212, A2500213, A2500214, A2500215, A2500216, A2500217, A2500218, A2500219, A2500220, A2500246, A2500247, A2500248, A2500249, A2500250, A2500251, A2500257, A2500258, A2500259, A2500260, A2500261, A2500262, A2500267, A2500268, A2500269, A2500273, A2500274, A2500275, A2500276, A2500277, A2500278, A2500295, A2500298, A2500299, A2500300; ***Addded 3/24/2026***Additional Lots Identified A2500318, A2500319, A2500320, A2500321, A2500322, A2500323, A2500324, A2500325, A2500326, A2500327, A2500328, A2500329, A2500330, A2500356, A2500357;

    Quantity: 1298454 units (1589674 - 3/5/26 Expansion)

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 97609
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.

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