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B Braun Medical Recalls
444 recalls on record · July 25, 2012 to June 10, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 21, 2018Medical DevicesFDA
B. Braun Medical, Inc. recalls Customer Epidural Anesthesia Tray. Product Catalog Number: 555234. Local anesthesia of the skin prior to insertion o
Hazard: B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
February 21, 2018Medical DevicesFDA
B. Braun Medical, Inc. recalls Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local anesthesia of the skin prior to insertion o
Hazard: B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
February 21, 2018Medical DevicesFDA
B. Braun Medical, Inc. recalls PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anesthesia of the skin prior to insertion of th
Hazard: B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
February 21, 2018Medical DevicesFDA
B. Braun Medical, Inc. recalls Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051, 552083, 552119, 555569. Local anesthes
Hazard: B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
February 21, 2018Medical DevicesFDA
B. Braun Medical, Inc. recalls Perifix Epidural AnesthesiaTray. Product Catalog Numbers: 551879, 551994, 552024. Local anesthesia of the skin prior
Hazard: B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
February 21, 2018Medical DevicesFDA
B. Braun Medical, Inc. recalls Pencan Spinal Needle Tray. Product Catalog Number: 333865. Local anesthesia of the skin prior to insertion of the re
Hazard: B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
February 21, 2018Medical DevicesFDA
B. Braun Medical, Inc. recalls Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. Local anesthesia of the skin prior to
Hazard: B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due tothe presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
February 21, 2018Medical DevicesFDA
B. Braun Medical, Inc. recalls Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin p
Hazard: B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due tothe presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
December 27, 2017DrugsFDA
B. Braun Medical Inc recalls 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895
Hazard: Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
May 31, 2017Medical DevicesFDA
B Braun Medical Inc recalls CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
Hazard: B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential for some blisters to be punctured resulting in a compromised sterility barrier.
December 7, 2016Medical DevicesFDA
B. Braun Medical, Inc. recalls Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
Hazard: Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.
November 9, 2016Medical DevicesFDA
B. Braun Medical, Inc. recalls Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anest
Hazard: B. Braun Medical Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tray which contains a drug component, 5% Lidocaine Hydrochloride and 7.5 % Dextrose Injection, USP that Hospira Inc. has recalled because the drug product does not meet the specification for color throughout shelf life.
October 19, 2016DrugsFDA
B. Braun Medical Inc recalls 5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, ND
Hazard: Non-Sterility: fungal contamination due to leaking containers.
June 8, 2016Medical DevicesFDA
B. Braun Medical, Inc. recalls Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inv
Hazard: BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit label writing is located.
June 8, 2016Medical DevicesFDA
B. Braun Medical, Inc. recalls Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of med
Hazard: BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit label writing is located.
June 1, 2016Medical DevicesFDA
B. Braun Medical, Inc. recalls WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per
Hazard: Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.
May 11, 2016Medical DevicesFDA
B Braun Medical Inc recalls Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and mon
Hazard: Potential leakage of conductivity sensors of the Dialog Dialysis machines.
May 11, 2016Medical DevicesFDA
B Braun Medical Inc recalls Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and m
Hazard: Potential leakage of conductivity sensors of the Dialog Dialysis machines.
May 11, 2016Medical DevicesFDA
B Braun Medical Inc recalls Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 20383
Hazard: Potential leakage of conductivity sensors of the Dialog Dialysis machines.
May 11, 2016Medical DevicesFDA
B Braun Medical Inc recalls Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 T
Hazard: Potential leakage of conductivity sensors of the Dialog Dialysis machines.
May 11, 2016Medical DevicesFDA
B Braun Medical Inc recalls Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Di
Hazard: Potential leakage of conductivity sensors of the Dialog Dialysis machines.
May 11, 2016Medical DevicesFDA
B Braun Medical Inc recalls Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can
Hazard: Potential leakage of conductivity sensors of the Dialog Dialysis machines.
October 28, 2015Medical DevicesFDA
B. Braun Medical, Inc. recalls Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pa
Hazard: Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.
May 13, 2015Medical DevicesFDA
B. Braun Medical, Inc. recalls CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anes
Hazard: There is a potential for a hole to be present in the outer tray of a limited number of pain control trays. This issue may cause the integrity of the sterile barrier to be compromised. A compromised sterile barrier poses a risk of inflammatory response and/or possible contamination of the spinal fluid or epidural space.
September 24, 2014Medical DevicesFDA
B. Braun Medical, Inc. recalls B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intrav
Hazard: The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The actual contents are a CT-1000-100.
July 16, 2014Medical DevicesFDA
B. Braun Medical, Inc. recalls STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
Hazard: Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled in the reverse position, resulting in the stopcock being closed when set in the open position and vise versa.
June 4, 2014Medical DevicesFDA
B. Braun Medical, Inc. recalls Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regio
Hazard: B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.
May 7, 2014DrugsFDA
B. Braun Medical Inc recalls Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun
Hazard: Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
May 7, 2014DrugsFDA
B. Braun Medical Inc recalls ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, S
Hazard: Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
May 7, 2014DrugsFDA
B. Braun Medical Inc recalls TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS, Sterile, Single Dose Container,
Hazard: Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.