B. Braun Medical, Inc. recalls
91 recalls in our records from 2012 to 2026: 64 FDA medical devices, 27 FDA drugs.
Recalls with full detail pages
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B Braun Medical Inc drug recall: 0.9% Sodium Chloride Injection
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
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B Braun Medical Inc drug recall: Lactated Ringer's Injection USP
Presence of Particulate matter.
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B Braun Medical Inc medical device recall: Spinal Needle procedure kits: Material Description
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due…
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B Braun Medical Inc drug recall: Lactated Ringer's Injection USP
Presence of Particulate Matter.
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B Braun Medical Inc medical device recall: B. Braun Hemodialysis Bloodlines
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
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B Braun Medical Inc medical device recall: Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE…
The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
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B Braun Medical Inc drug recall: Lactated Ringers's Injection USP
Presence of Particulate Matter
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B Braun Medical Inc medical device recall: Microbore Extension Set with 0.2 Micron Filter. Catalog Number:…
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…
Earlier and other recalls
These link to the official agency notice.
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B Braun Medical Inc medical device recall: B Braun SAFSITE Injection Site Official notice ↗
Potential for leakage and backflow at the Safsite valve.
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B Braun Medical Inc medical device recall: Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK… Official notice ↗
Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
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B Braun Medical Inc medical device recall: Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE… Official notice ↗
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to…
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B Braun Medical Inc drug recall: Sterile Water for Injection USP Official notice ↗
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
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B Braun Medical Inc medical device recall: Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged… Official notice ↗
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
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B Braun Medical Inc medical device recall: ADDitIV utilized in gravity IV administration sets and pump… Official notice ↗
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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B Braun Medical Inc medical device recall: PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x… Official notice ↗
Potential for the lid of the catheter connector to be in the incorrect position.
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B Braun Medical Inc drug recall: Sterile Water For Injection Usp Official notice ↗
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
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B Braun Medical Inc drug recall: Lactated Ringer's Injection USP Official notice ↗
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
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B Braun Medical Inc drug recall: 0.9% Sodium Chloride Injection USP Official notice ↗
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
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B. Braun Medical Inc drug recall: 0.9% Sodium chloride Irrigation USP Official notice ↗
Presence of Particulate Matter
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B Braun Medical Inc medical device recall: Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in Official notice ↗
Increased risk for valve housing detachment causing leakage.
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B. Braun Medical, Inc. medical device recall: Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for… Official notice ↗
Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller…
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B Braun Medical Inc medical device recall: SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood… Official notice ↗
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during…
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B. Braun Medical, Inc. medical device recall: AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed… Official notice ↗
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.
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B Braun Medical Inc medical device recall: Infusomat Space Infusion System/ Large Volume Pump Official notice ↗
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…
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B. Braun Medical Inc drug recall: 0.9% Sodium Chloride Injection USP Official notice ↗
Presence of Particulate Matter
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B Braun Medical Inc medical device recall: Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump… Official notice ↗
Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health…
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B. Braun Medical, Inc. medical device recall: OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered… Official notice ↗
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the…
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B Braun Medical Inc medical device recall: Stimuplex A Official notice ↗
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
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B. Braun Medical Inc drug recall: Lactated Ringer's Injection USP Official notice ↗
Lack of assurance of sterility: bags have the potential to leak..
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B. Braun Medical Inc drug recall: Potassium Chloride for Injection Concentrate USP Official notice ↗
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.
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B. Braun Medical, Inc. medical device recall: Epidural tray. PERIFIX 17 Ga. x 3-1/2 in Official notice ↗
Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other…
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B. Braun Medical, Inc. medical device recall: Infusomat Administration Sets as listed below: 362031 Infusomat Space… Official notice ↗
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…
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B. Braun Medical, Inc. medical device recall: Ft1000S Fluid Transfer Set Official notice ↗
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…
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B. Braun Medical, Inc. medical device recall: 8713051U Official notice ↗
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…
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B. Braun Medical, Inc. medical device recall: B. Braun NORM-JECT Luer Solo Official notice ↗
The sterile blister packaging may be damaged, and sterility may be compromised
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B. Braun Medical, Inc. medical device recall: Perifix¿ / Epidural anesthesia set Official notice ↗
Product may be mislabeled with an incorrect lid stock label.
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B. Braun Medical Inc. drug recall: 0.9% Sodium Chloride Injection USP Official notice ↗
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
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B. Braun Medical Inc. drug recall: 0.9% Sodium Chloride Injection USP Official notice ↗
Lack of assurance of sterility: bags have the potential to leak.
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B. Braun Medical, Inc. medical device recall: Perifix¿ / Epidural anesthesia kit Official notice ↗
Kits were assembled with the incorrect Filter Straw.
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B. Braun Medical Inc drug recall: Heparin Sodium Official notice ↗
Subpotent: Low anti-factor IIa Potency.
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B. Braun Medical Inc drug recall: Heparin Sodium Official notice ↗
Subpotent Drug: low Anti-Factor IIa potency.
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B. Braun Medical Inc. drug recall: 0.9% Sodium Chloride Injection Official notice ↗
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…
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B. Braun Medical, Inc. drug recall: 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx… Official notice ↗
Lack of sterility assurance: Bags have the potential to leak.
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B. Braun Medical, Inc. medical device recall: ULTRASITE US04TL Smallbore T-Port Extension Set Official notice ↗
The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in…
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B Braun Medical Inc medical device recall: Introcan Safety FEP 14G Official notice ↗
Potential for leakage at the catheter hub.
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B Braun Medical Inc medical device recall: Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis… Official notice ↗
Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in…
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B Braun Medical Inc medical device recall: PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that… Official notice ↗
Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy…
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B. Braun Medical, Inc. drug recall: 0.9% Sodium Chloride Injection USP Official notice ↗
Lack of sterility assurance: leaking bags
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B. Braun Medical, Inc. medical device recall: Dispensing Pins for Air Inlet Filter Official notice ↗
This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of…
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B. Braun Medical, Inc. medical device recall: 15 drops/ml Official notice ↗
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and…
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B. Braun Medical, Inc. medical device recall: Infusomat Space Volumetric Pump Administration Set Official notice ↗
There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen…
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B. Braun Medical, Inc. medical device recall: Filtered Triple-Leg Extension Set - Intravascular administration set.… Official notice ↗
BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
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B Braun Medical, Inc. medical device recall: APEX Compounding System Control Panel Module Official notice ↗
There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered…
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B. Braun Medical Inc drug recall: Ceftazidime for Injection USP and Dextrose for Injection USP Official notice ↗
Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
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B. Braun Medical, Inc. medical device recall: Outlook Safety Infusion System Y-type Blood Set Official notice ↗
Potential for leakage at the joint between the blood filters and tubing
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B. Braun Medical, Inc. medical device recall: B.Braun Infusomat Space Volumetric Infusion Pump Administration Set Official notice ↗
Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).
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B. Braun Medical, Inc. medical device recall: ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114 Official notice ↗
The filter capacity is not achieved due to damage of the filter membrane.
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B. Braun Medical Inc drug recall: Heparin Sodium 25 Official notice ↗
Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within…
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B. Braun Medical, Inc. medical device recall: Conti Tuohy Ultra 360 2 In Cont Pnb Set Official notice ↗
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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B. Braun Medical, Inc. medical device recall: 26-Lead Transfer Set for use with APEX¿ Compounding System Official notice ↗
There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on the…
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B. Braun Medical, Inc. medical device recall: Space Pump IV Set Official notice ↗
There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter.
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B. Braun Medical Inc drug recall: 0.9% Sodium Chloride Irrigation USP Official notice ↗
Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to…
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B. Braun Medical, Inc. medical device recall: Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers:… Official notice ↗
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…
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B. Braun Medical Inc drug recall: 0.25% Acetic Acid Irrigation USP Official notice ↗
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
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B Braun Medical Inc medical device recall: CytoGuard Closed Luer Connector Official notice ↗
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…
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B. Braun Medical, Inc. medical device recall: Sterile IV Start Kits 50 units/trays per case Convenience kit for IV… Official notice ↗
Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.
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B. Braun Medical, Inc. medical device recall: Affected Pain Control Tray Component Official notice ↗
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 %…
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B. Braun Medical Inc drug recall: 5% Dextrose Injection USP Official notice ↗
Non-Sterility: fungal contamination due to leaking containers.
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B. Braun Medical, Inc. medical device recall: Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite… Official notice ↗
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,…
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B. Braun Medical, Inc. medical device recall: WHIN Infusion Set - 90 Huber Needle and Wing Official notice ↗
Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.
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B Braun Medical Inc medical device recall: Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L… Official notice ↗
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
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B. Braun Medical, Inc. medical device recall: Perifix Continous Epidural Anesthesia Pain Control Trays Official notice ↗
Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.
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B. Braun Medical, Inc. medical device recall: CONTIPLEX Continuous Peripheral Nerve Block Tray Official notice ↗
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…
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B. Braun Medical, Inc. medical device recall: B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo… Official notice ↗
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…
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B. Braun Medical, Inc. medical device recall: Stopcock Ext. Set W/ 3-Way Stopcock With Inj. Site And Spinlock… Official notice ↗
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…
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B. Braun Medical, Inc. medical device recall: Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer… Official notice ↗
B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.
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B. Braun Medical Inc drug recall: Cefoxitin for Injection and Dextrose Injection Official notice ↗
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
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B. Braun Medical, Inc. medical device recall: SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿… Official notice ↗
Complaints were received reporting leakage on certain lots of SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites.The SAFSITE¿ Injection Site…
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B. Braun Medical, Inc. medical device recall: B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally… Official notice ↗
Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in…
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B. Braun Medical Inc drug recall: Cefepime for Injection USP and Dextrose Injection USP Official notice ↗
Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a…
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B. Braun Medical Inc drug recall: 0.45% Sodium Chloride Injection USP Official notice ↗
Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
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B. Braun Medical, Inc. medical device recall: B. Braun Introcan Safety IV Catheter PUR 24G Official notice ↗
One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.
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B. Braun Medical, Inc. medical device recall: 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with… Official notice ↗
Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause…
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B Braun Medical, Inc. medical device recall: Outlook ES pump is intended for use with B. Braun Medical Inc.… Official notice ↗
This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on August 26, 2011 due to an issue in which the Outlook ES Safety…
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B. Braun Medical, Inc. medical device recall: Outlook Safety Infusion System Burette Set. For intravenous fluid… Official notice ↗
Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the…
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B Braun Medical, Inc. medical device recall: Outlook ES pump is intended for use with B. Braun Medical Inc.… Official notice ↗
B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100…
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B Braun Medical, Inc. medical device recall: Outlook ES pump is intended for use with B. Braun Medical Inc.… Official notice ↗
B. Braun Medical Inc. has become aware of an issue with the Outlook ES Safety Infusion System. The key panel may fail to function as intended if the underlying circuitry…
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B Braun Medical, Inc. medical device recall: Outlook ES pump is intended for use with B. Braun Medical Inc.… Official notice ↗
This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August, 2011 due to an issue in the Outlook ES Safety…
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B. Braun Medical, Inc. medical device recall: Diacap(R) Ultra Dialysis Fluid Filter Official notice ↗
There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane permeability…
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B. Braun Medical, Inc. medical device recall: Space Pump Pole Clamps for the Infusomat Space Pump Official notice ↗
Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps.
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B. Braun Medical, Inc. medical device recall: Infusomat(R) Space Pump Official notice ↗
Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip is…
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.