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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.
June 19, 2024Medical DevicesFDA
B Braun Medical Inc recalls Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502
Hazard: The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
June 19, 2024Medical DevicesFDA
B Braun Medical Inc recalls Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
Hazard: The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
June 19, 2024Medical DevicesFDA
B Braun Medical Inc recalls Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260
Hazard: The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
June 19, 2024Medical DevicesFDA
B Braun Medical Inc recalls Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
Hazard: The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
April 10, 2024DrugsFDA
B. Braun Medical Inc recalls Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7
Hazard: Lack of assurance of sterility: bags have the potential to leak..
March 20, 2024DrugsFDA
B. Braun Medical Inc recalls Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc.,
Hazard: Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
February 28, 2024Medical DevicesFDA
B. Braun Medical, Inc. recalls Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of device
Hazard: Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
February 28, 2024Medical DevicesFDA
B. Braun Medical, Inc. recalls Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass
Hazard: Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
December 13, 2023Medical DevicesFDA
B. Braun Medical, Inc. recalls Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 3
Hazard: In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death.
November 15, 2023Medical DevicesFDA
B. Braun Medical, Inc. recalls BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.
Hazard: Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
November 15, 2023Medical DevicesFDA
B. Braun Medical, Inc. recalls 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.
Hazard: Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
November 15, 2023Medical DevicesFDA
B. Braun Medical, Inc. recalls ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.
Hazard: Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
November 15, 2023Medical DevicesFDA
B. Braun Medical, Inc. recalls THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-
Hazard: Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
November 15, 2023Medical DevicesFDA
B. Braun Medical, Inc. recalls TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
Hazard: Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
November 15, 2023Medical DevicesFDA
B. Braun Medical, Inc. recalls 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.
Hazard: Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
November 15, 2023Medical DevicesFDA
B. Braun Medical, Inc. recalls AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.
Hazard: Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
November 15, 2023Medical DevicesFDA
B. Braun Medical, Inc. recalls SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.
Hazard: Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
November 15, 2023Medical DevicesFDA
B. Braun Medical, Inc. recalls FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution conta
Hazard: Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
November 1, 2023Medical DevicesFDA
B. Braun Medical, Inc. recalls 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
Hazard: Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.
November 1, 2023Medical DevicesFDA
B. Braun Medical, Inc. recalls 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Hazard: Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.
October 4, 2023Medical DevicesFDA
B. Braun Medical, Inc. recalls B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metere
Hazard: The sterile blister packaging may be damaged, and sterility may be compromised
October 4, 2023Medical DevicesFDA
B. Braun Medical, Inc. recalls B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dos
Hazard: The sterile blister packaging may be damaged, and sterility may be compromised
September 27, 2023Medical DevicesFDA
B. Braun Medical, Inc. recalls Perifix¿ / Epidural anesthesia set, medicated
Hazard: Product may be mislabeled with an incorrect lid stock label.
August 16, 2023DrugsFDA
B. Braun Medical Inc. recalls 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, ND
Hazard: Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
July 19, 2023DrugsFDA
B. Braun Medical Inc. recalls 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-352
Hazard: Lack of assurance of sterility: bags have the potential to leak.
July 5, 2023Medical DevicesFDA
B. Braun Medical, Inc. recalls Design Options¿ / Epidural anesthesia kit (10 count carton)
Hazard: Kits were assembled with the incorrect Filter Straw.
July 5, 2023Medical DevicesFDA
B. Braun Medical, Inc. recalls Perifix¿ / Epidural anesthesia kit (10 count carton)
Hazard: Kits were assembled with the incorrect Filter Straw.
May 24, 2023DrugsFDA
B. Braun Medical Inc recalls Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B.
Hazard: Subpotent: Low anti-factor IIa Potency.
March 15, 2023DrugsFDA
B. Braun Medical Inc recalls Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.B
Hazard: Subpotent Drug: low Anti-Factor IIa potency.
March 1, 2023DrugsFDA
B. Braun Medical Inc. recalls 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, ND
Hazard: Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.