The Recall Desk

Manufacturer

B. Braun Medical, Inc.

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

What the numbers show

Total
446
Critical
9
Severe
40
Most recent
2026-09-09

Of the 446 recalls from B. Braun Medical, Inc. we have scored against our rubric, 9 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 40 (9%) are Severe.

Which agencies issued them

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.

401–425 of 446

  • ModerateFDA (Drugs)·D-0112-2018·2017-12-27

    B. Braun Recalls Acetic Acid Irrigation Due to Particulate Matter

    B. Braun Medical Inc. is recalling 2,576 containers of 0.25% Acetic Acid Irrigation USP due to the presence of polyethylene particulate matter.

    Product
    ACETIC ACID — ACETIC ACID (ACETIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2155-2017·2017-05-31

    B. Braun Recalls CytoGuard Closed Luer Connectors Due to Sterility Concerns

    B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connectors because some blisters may be punctured, compromising the sterility barrier.

    Product
    CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0691-2017·2016-12-07

    B. Braun Recalls Sterile IV Start Kits Due to Sterility Testing

    B. Braun Medical is recalling 15,950 Sterile IV Start Kits because non-routine sterility testing returned positive results.

    Product
    Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0327-2017·2016-11-09

    B. Braun Recalls Spinal Anesthesia Trays with Lidocaine Component

    B. Braun Medical is voluntarily recalling specific lots of Custom Spinal Anesthesia Trays because the lidocaine component does not meet color specifications.

    Product
    Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional anesthesia
    Category
    Medical Device
    Distribution
    6 states
  • CriticalFDA (Drugs)·D-0094-2017·2016-10-19

    B. Braun Recalls 5% Dextrose Injection Due to Fungal Contamination

    B. Braun Medical Inc. is recalling 57,408 units of 5% Dextrose Injection USP due to non-sterility caused by fungal contamination from leaking containers.

    Product
    5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1906-2016·2016-06-08

    B. Braun Medical Recalls Non-Vented Dispensing Pins Due to Packaging Tears

    B. Braun Medical is recalling approximately 11,000 Non-Vented Dispensing Pins because the outer blister packaging may tear, potentially compromising the product label.

    Product
    Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1907-2016·2016-06-08

    B. Braun Recalls Non-Vented Dispensing Pins Due to Packaging Tears

    B. Braun Medical is recalling 11,000 Non-Vented Dispensing Pins because the outer blister packaging may tear, potentially compromising the device.

    Product
    Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2016·2016-06-01

    B. Braun Recalls WHIN Infusion Sets Due to Needle Protrusion Risk

    B. Braun Medical is recalling WHIN Infusion Sets because the Huber needle tip may protrude from the needle guard, posing a safety risk to patients.

    Product
    WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular ports.
    Category
    Medical Device
    Distribution
    18 states
  • CriticalFDA (Devices)·Z-1535-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Conductivity Sensors Due to Leakage Risk

    B Braun Medical Inc is recalling 68 Dialog+ Hemodialysis Conductivity Sensors due to a potential leakage hazard. The units were distributed nationwide to various states and territories.

    Product
    Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1536-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Conductivity Sensors Due to Leakage Risk

    B Braun Medical Inc is recalling 147 Dialog+ Hemodialysis Conductivity Sensors due to potential leakage. The sensors are used in dialysis machines for kidney failure patients.

    Product
    Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis cen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1531-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage Risk

    B Braun Medical Inc is recalling 370 Dialog+ Hemodialysis machines because conductivity sensors may leak. The recall covers units distributed nationwide and in Puerto Rico.

    Product
    Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health ce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1532-2016·2016-05-11

    B Braun Dialog+ Hemodialysis Machines Recalled for Potential Sensor Leakage

    B Braun Medical Inc. is recalling 40 Dialog+ Hemodialysis machines due to a potential leakage issue with conductivity sensors.

    Product
    Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage

    B Braun Medical Inc is recalling 318 Dialog+ Hemodialysis machines because conductivity sensors may leak. The recall covers units distributed nationwide.

    Product
    Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hosp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1534-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage Risk

    B Braun Medical Inc is recalling 90 Dialog+ Hemodialysis machines because conductivity sensors may leak. The recall covers units distributed nationwide.

    Product
    Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 203837 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0150-2016·2015-10-28

    B. Braun Recalls Perifix Epidural Anesthesia Trays Due to Discoloration

    B. Braun Medical is recalling 433 Perifix Continuous Epidural Anesthesia Pain Control Trays because the DuraPrep solution may be discolored from unintended sterilant exposure.

    Product
    Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1576-2015·2015-05-13

    B. Braun Medical Recalls Pain Control Trays Due to Sterile Barrier Risk

    B. Braun Medical is recalling specific pain control trays because a potential hole in the outer tray may compromise the sterile barrier, posing a risk of contamination.

    Product
    CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2655-2014·2014-09-24

    B. Braun AccuFlo Elastomeric Infusion Device Labeling Recall

    B. Braun Medical is recalling AccuFlo infusion devices in Missouri due to a mismatch between inner and outer packaging labels.

    Product
    B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2022-2014·2014-07-16

    B. Braun Stopcock Extension Sets Recalled for Reverse Assembly Defect

    B. Braun Medical is recalling 10,835 Stopcock Extension Sets because some stopcocks are assembled in reverse, causing them to close when set to open.

    Product
    STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1666-2014·2014-06-04

    B. Braun Recalls Sprotte Spinal Needles Missing Introducer Needles

    B. Braun Medical is recalling 24-gauge Sprotte Spinal Needles and Trays because the accompanying introducer needles are missing.

    Product
    Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1273-2014·2014-05-07

    B. Braun Recalls TrophAmine Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling TrophAmine (10% Amino Acid Injection) units due to visible particulate matter found in reserve samples.

    Product
    TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-9341-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1269-2014·2014-05-07

    B. Braun Recalls Cefazolin Sodium Injectable Due to Particulate Matter

    B. Braun Medical Inc. is recalling Cefazolin Sodium injectable products because visible particulate matter was found in reserve sample units.

    Product
    CEFAZOLIN SODIUM — CEFAZOLIN SODIUM (CEFAZOLIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1272-2014·2014-05-07

    B. Braun Recalls 15% Amino Acids Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling 15% Amino Acids Injection products due to visible particulate matter found in reserve sample units.

    Product
    15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy Bulk Package, Not For Direct Infusion, For Intravenous Use, Sterile, Single Dose Container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-3200-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1265-2014·2014-05-07

    B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection USP due to visible particulate matter found in reserve sample units.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1274-2014·2014-05-07

    B. Braun Recalls ProcalAmine Injectable Due to Particulate Matter

    B. Braun Medical Inc. is recalling ProcalAmine injectable products due to visible particulate matter found in reserve samples.

    Product
    ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1915-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1270-2014·2014-05-07

    B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection USP due to visible particulate matter found in reserve samples.

    Product
    0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, Sterile, Single Dose Container, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-4000-55
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

B Braun Medical (United States)

company in Bethlehem, United States

Country
United States
Founded
1839

Official website

Source: Wikidata (Q30264023), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.