The Recall Desk

Manufacturer

B Braun Medical Inc

173 recalls in our database name B Braun Medical Inc as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

151–173 of 173

  • SevereFDA (Devices)·Z-2176-2025·2025-08-13

    B. Braun Medical IV Extension Set Labeled with Incorrect Filter Description

    B. Braun Medical is recalling 34,825 Microbore Extension Sets due to incorrect labeling claiming air-eliminating capability the device does not possess.

    Product
    Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Drugs)·D-0491-2025·2025-07-02

    Sodium Chloride Injection recalled for packaging sterility defects

    B Braun Medical is recalling 187,656 containers of 0.9% Sodium Chloride Injection USP due to pinholes in packaging that compromise sterility assurance in this intravenous product.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1397-2025·2025-03-26

    IV Catheter Valve Housing May Detach and Cause Leakage

    B. Braun Medical is recalling Introcan Safety 3 IV catheters because the valve housing may detach, causing fluid leakage. Approximately 28,200 units are affected.

    Product
    Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-3177-2024·2024-09-25

    Hemodialysis tubing connector may not fully insert, risking flow occlusion

    B. Braun Medical is recalling STREAMLINE LONG hemodialysis bloodline tubing because the patient connector may fail to fully insert into the Locksite, potentially causing blood flow obstruction during dialysis treatment.

    Product
    STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3175-2024·2024-09-25

    Hemodialysis bloodline tubing recalled for improper connector insertion risk

    B. Braun is recalling approximately 4.98 million STREAMLINE FRESENIUS FOR DAVITA hemodialysis bloodline tubes due to risk of improper connector insertion, which could cause blood flow occlusion during dialysis treatment.

    Product
    STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095DA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3173-2024·2024-09-25

    Hemodialysis Bloodline Tubing Recall Over Incomplete Connector Insertion Risk

    B Braun is recalling SL BLOODLINE FOR FMC 2008 SERIES hemodialysis tubing nationwide due to incomplete connector insertion that may cause blood flow restrictions during treatment.

    Product
    SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3176-2024·2024-09-25

    Hemodialysis bloodline connector insertion defect may cause flow restriction

    B Braun Medical is recalling hemodialysis bloodline tubing because the patient connector may not fully insert into the device, potentially blocking blood flow and delaying treatment. Affected units were distributed nationwide.

    Product
    STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3174-2024·2024-09-25

    Hemodialysis tubing may fail to flow if connector is incompletely inserted

    B Braun's STREAMLINE FRESENIUS bloodline tubing used in hemodialysis may have a design issue where incomplete insertion of the patient connector prevents proper blood flow during certain procedures. Patients receiving dialysis may experience treatment delays.

    Product
    STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3178-2024·2024-09-25

    Streamline Bloodline Hemodialysis Sets Recalled for Patient Connector Defect

    B. Braun is recalling 9,864,165 Streamline Bloodline Sets nationwide due to incomplete patient connector insertion. The defect may restrict fluid flow during hemodialysis and cause therapy delays.

    Product
    STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2972-2024·2024-09-18

    Infusomat Space Infusion Pump Recall Due to Sensor Malfunction

    B Braun is recalling the Infusomat Space Infusion Pump due to a sensor malfunction that can trigger false alarms, risking improper medication delivery.

    Product
    Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2435-2024·2024-07-31

    Perfusor Space syringe pump recalled for Cardinal Health syringe incompatibility

    B Braun is recalling Perfusor Space syringe pumps because manufacturing changes to Cardinal Health Monoject syringes may cause incompatibility, resulting in dosing errors or delayed treatment.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space Syringe Pump, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2436-2024·2024-07-31

    Perfusor Space infusion pump syringe incompatibility may cause dosing error

    B Braun is recalling Perfusor Space infusion pump kits because Cardinal Health Monoject syringes have manufacturing changes that make them incompatible, potentially causing overdose, underdose, or delayed therapy.

    Product
    Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusion Pump Kit, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2437-2024·2024-07-31

    Perfusor Space Syringe Pump Recalled for Monoject Syringe Incompatibility Risk

    B Braun's Perfusor Space infusion pump may be incompatible with Cardinal Health Monoject syringes affected by manufacturing changes, creating risks of overdose, underdose, and delayed therapy.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Product Description: Perfusor Space Syringe Pump, Non-Wireless, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2433-2024·2024-07-31

    Infusion Pump Syringe Compatibility Issue May Cause Overdose or Underdose

    B Braun is recalling Perfusor Space infusion pumps due to syringe compatibility issues with Cardinal Health Monoject syringes. The incompatibility may cause overdose, underdose, therapy delays, and alarm failures.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2434-2024·2024-07-31

    Perfusor Space Syringe Pump Recalled Due to Monoject Syringe Incompatibility

    B Braun Medical's Perfusor Space Syringe Pump may not properly recognize Cardinal Health Monoject syringes due to manufacturing changes, risking medication overdose, underdose, or therapy delays.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Product Description: Perfusor Space Syringe Pump, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2133-2024·2024-06-19

    Stimuplex A Anesthesia Needles Recalled for Undisclosed DEHP in Glue

    B Braun Medical Inc is recalling 108,811 units of Stimuplex A anesthesia needles because the devices are labeled as DEHP-free but the glue contains traces of DEHP.

    Product
    Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2024·2024-06-19

    Stimuplex A Nerve Needles Recalled for Mislabeled DEHP Content

    B Braun Medical Inc is recalling over 1.1 million Stimuplex A nerve block needles labeled as DEHP-free, but the adhesive contains traces of DEHP. The mislabeling poses a risk to users who selected the product specifically to avoid DEHP exposure.

    Product
    Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2131-2024·2024-06-19

    Stimuplex A Injection Needles Recalled for DEHP Mislabeling

    B Braun Medical Inc is recalling Stimuplex A injection needles because the devices are labeled as DEHP-free, but the glue used contains traces of DEHP. The recall affects 20,850 units distributed in the US and Canada.

    Product
    Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2132-2024·2024-06-19

    Medical device nerve block needles incorrectly labeled as DEHP-free

    Stimuplex A nerve block needles labeled as DEHP-free contain trace amounts of DEHP in the adhesive. B Braun is recalling approximately 1.78 million units distributed in the US and Canada.

    Product
    Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0009-2023·2022-10-12

    Introcan Safety Catheter Recalled for Potential Leakage at Hub

    B. Braun is recalling 94,000 Introcan Safety FEP 14G catheters due to potential leakage at the catheter hub. Affected units were distributed in the US and Canada.

    Product
    Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0873-2022·2022-04-20

    Hemodialysis Conductivity Sensors recalled for potential cracks and dialysate leaks

    B Braun Medical Inc is recalling conductivity sensors used in Dialog hemodialysis systems due to potential cracking during use, which could cause leaks in the dialysate circuit and improper ultrafiltration. Affected patients should contact their healthcare provider.

    Product
    Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0872-2022·2022-04-20

    Conductivity Sensors in Dialog Hemodialysis Systems May Crack and Leak

    B Braun Medical Inc is recalling conductivity sensors used in Dialog and Dialog+ hemodialysis systems due to potential cracks that could cause dialysate circuit leaks, affecting ultrafiltration during treatment.

    Product
    Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0819-2022·2022-03-30

    Infusion Pump Risk of Malfunction in B. Braun Perfusor Space Devices

    B. Braun is recalling 6 Perfusor Space infusion pump units that may not function properly due to inadequate inspection, potentially causing incorrect medication dosing and therapy delays.

    Product
    PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
    Category
    Medical Device
    Distribution
    2 states