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B BRAUN MEDICAL INC

B BRAUN MEDICAL INC Recalls

All product recalls associated with B BRAUN MEDICAL INC.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 83 recalls

Pain Management Tray (B Braun) – Catheter Connector Misalignment (2025)

Potential for the lid of the catheter connector to be in the incorrect position.

Moderate

FDASep 18, 2025Nationwide• B BRAUN MEDICAL INC

PERIFIX Spinal Epidural Tray (B Braun) – Connector Position Problem (2025)

Potential for the lid of the catheter connector to be in the incorrect position.

Moderate

FDASep 18, 2025Nationwide• B BRAUN MEDICAL INC

Sterile Water Injection (B Braun Medical) - Sterility Concern (2025)

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

Class IIModerate

FDA

123 4 5

Page 2 of 5Next

Aug 26, 2025

Nationwide

• B BRAUN MEDICAL INC

Sodium Chloride Irrigation (B Braun Medical) - Sterility Concern (2025)

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

Class IIModerate

FDAAug 26, 2025Nationwide• B BRAUN MEDICAL INC

Sodium Chloride Injection (B Braun Medical) - Particulate Matter (2025)

Presence of Particulate Matter.

Class IHigh

FDAAug 18, 2025Nationwide• B BRAUN MEDICAL INC

Lactated Ringer's Injection (B Braun Medical) - Particulate Matter (2025)

Presence of Particulate Matter

Class IHigh

FDAAug 18, 2025Nationwide• B BRAUN MEDICAL INC

Sodium Chloride Injection (B Braun) - Sterility Concern (2025)

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Class IIModerate

FDAAug 4, 2025Nationwide• B BRAUN MEDICAL INC

Lactated Ringer's Injection (B Braun) - Sterility Concern (2025)

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Class IIModerate

FDAAug 4, 2025Nationwide• B BRAUN MEDICAL INC

Microbore Extension Set (B.Braun) – Labeling Inaccuracy (2025)

Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common to air eliminating filters.

Moderate

FDAJul 9, 2025AZ, CA, CO +29 more• B BRAUN MEDICAL INC

Sodium Chloride Injection (B Braun) – Sterility Compromise (2025)

Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.

Class IIModerate

FDAJun 16, 2025Nationwide• B BRAUN MEDICAL INC

Sodium Chloride Irrigation (B. Braun) – Particulate Matter (2025)

Presence of Particulate Matter

Class IIModerate

FDAMar 31, 2025Nationwide• B. Braun Medical Inc

Introcan Safety 3 IV Catheter (B Braun) – Valve Housing Risk (2025)

Increased risk for valve housing detachment causing leakage.

Moderate

FDAFeb 17, 2025CA, FL, GA +13 more• B Braun Medical Inc

Spinal/Epidural Tray (B. Braun) – Catheter Connector Mismatch (2024)

Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.

Moderate

FDADec 4, 2024Nationwide• B. Braun Medical, Inc.

Streamline Dialog Bloodline (B Braun) - Connector Insertion Risk (2024)

Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method

Moderate

FDAAug 15, 2024Nationwide• B Braun Medical Inc

Anesthesia Extension Set (B. Braun) - Connector Leakage Risk (2024)

Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.

Moderate

FDAAug 8, 2024Nationwide• B. Braun Medical, Inc.

Infusomat Space Pump (B Braun) - Occlusion Sensor Malfunction (2024)

Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected.

Moderate

FDAAug 7, 2024AL, CA, GA +3 more• B Braun Medical Inc

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B BRAUN MEDICAL INC Recalls

Recall Summary

Pain Management Tray (B Braun) – Catheter Connector Misalignment (2025)

PERIFIX Spinal Epidural Tray (B Braun) – Connector Position Problem (2025)

Sterile Water Injection (B Braun Medical) - Sterility Concern (2025)

Sodium Chloride Irrigation (B Braun Medical) - Sterility Concern (2025)

Sodium Chloride Injection (B Braun Medical) - Particulate Matter (2025)

Lactated Ringer's Injection (B Braun Medical) - Particulate Matter (2025)

Sodium Chloride Injection (B Braun) - Sterility Concern (2025)

Lactated Ringer's Injection (B Braun) - Sterility Concern (2025)

Microbore Extension Set (B.Braun) – Labeling Inaccuracy (2025)

Sodium Chloride Injection (B Braun) – Sterility Compromise (2025)

Sodium Chloride Irrigation (B. Braun) – Particulate Matter (2025)

Introcan Safety 3 IV Catheter (B Braun) – Valve Housing Risk (2025)

Spinal/Epidural Tray (B. Braun) – Catheter Connector Mismatch (2024)

Streamline Dialog Bloodline (B Braun) - Connector Insertion Risk (2024)

SL Bloodline for FMC (B Braun) - Connector Insertion Risk (2024)

Streamline Long Tubing (B Braun) - Connector Insertion Risk (2024)

Streamline Bloodline Long (B Braun) - Connector Insertion Risk (2024)

Streamline Fresenius Tubing (B Braun) - Connector Insertion Risk (2024)

Anesthesia Extension Set (B. Braun) - Connector Leakage Risk (2024)

Infusomat Space Pump (B Braun) - Occlusion Sensor Malfunction (2024)