B. Braun Medical recalls
53 official recalls and safety alerts involving B. Braun Medical since 2021-10, from FDA · Device, FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with B. Braun Medical or the relevant agency.
- 2026-09-16
USB BRAUN MEDICAL INC recalls 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA…
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
- 2026-09-09
- US
B Braun Medical Inc recalls Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
FDA · DeviceB Braun Medical IncWorldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI,…Official notice → - 2026-09-02
- US
- 2026-06-10
- US
B Braun Medical Inc recalls Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with…
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a…
- US
B Braun Medical Inc recalls Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version: N/A Product…
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 potential cracking of the butyrate tubing (outside…
FDA · DeviceB Braun Medical IncUS Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.Official notice → - 2026-05-13
- US
- 2026-04-29
- US
B BRAUN MEDICAL INC recalls DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- 2026-04-22
- US
B Braun Medical Inc recalls B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
FDA · DeviceB Braun Medical IncWorldwide distribution - US Nationwide and the country of Canada.Official notice → - 2026-03-11
- US
B Braun Medical Inc recalls Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device…
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
FDA · DeviceB Braun Medical IncWorldwide - US Nationwide distribution in the state of TX and the country of…Official notice → - 2025-12-03
- US
B Braun Medical Inc recalls Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space…
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
FDA · DeviceB Braun Medical IncWorldwide distribution - US distribution and international distribution to…Official notice → - 2025-10-29
- US
B BRAUN MEDICAL INC recalls Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version:…
The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
- 2025-10-15
- US
B BRAUN MEDICAL INC recalls PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed…
Potential for the lid of the catheter connector to be in the incorrect position.
FDA · DeviceB BRAUN MEDICAL INCNationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS,…Official notice → - 2025-09-24
- US
B BRAUN MEDICAL INC recalls 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA,…
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
- 2025-09-17
- US
B.Braun Medical S.A.S. recalls Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product…
The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
- 2025-09-10
- US
- US
- 2025-08-20
- US
B BRAUN MEDICAL INC recalls 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun…
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
- 2025-08-13
- US
B BRAUN MEDICAL INC recalls Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
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 for removal of air and does not feature an air…
FDA · DeviceB BRAUN MEDICAL INCUS distribution to AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, MA, MD, ME, MI, MN,…Official notice → - 2025-07-02
- US
B BRAUN MEDICAL INC recalls 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical…
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
- 2025-04-16
- US
B. Braun Medical Inc recalls 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc.,…
Presence of Particulate Matter
FDA · DrugB. Braun Medical IncProduct was distributed to 12 distributors who may have further distributed…Official notice → - 2025-03-26
- US
B Braun Medical Inc recalls Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Increased risk for valve housing detachment causing leakage.
FDA · DeviceB Braun Medical IncDomestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA,…Official notice → - 2025-02-05
- US
B. Braun Medical, Inc. recalls Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural…
Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore…
FDA · DeviceB. Braun Medical, Inc.US Nationwide distribution in the states of MO, OK.Official notice → - 2024-09-25
- US
B Braun Medical Inc recalls SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.…
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient…
- US
B. Braun Medical, Inc. recalls AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
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.
- 2024-09-18
- US
B Braun Medical Inc recalls Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
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 operation triggering false downstream and upstream…
- 2024-08-28
- US
- 2024-07-31
- US
B Braun Medical Inc recalls Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U…
Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with…
FDA · DeviceB Braun Medical IncDomestic distribution nationwide. International distribution to Canada.Official notice → - 2024-07-24
- US
B. Braun Medical, Inc. recalls OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication…
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of…
FDA · DeviceB. Braun Medical, Inc.Worldwide distribution - US Nationwide and the country of Canada.Official notice → - 2024-06-19
- US
B Braun Medical Inc recalls Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
FDA · DeviceB Braun Medical IncWorldwide distribution - US Nationwide and the country of Canada.Official notice → - 2024-04-10
- US
B. Braun Medical Inc recalls Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
Lack of assurance of sterility: bags have the potential to leak..
- 2024-03-20
- US
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., Bethlehem, PA…
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.
- 2024-02-28
- US
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 devices intended for the…
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.
- US
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 Luer Lock LOR Tray…
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.
- 2023-12-13
- US
B. Braun Medical, Inc. recalls Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming…
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.…
- 2023-11-15
- US
B. Braun Medical, Inc. recalls TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
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…
FDA · DeviceB. Braun Medical, Inc.Worldwide distribution - US Nationwide and the countries of Canada and…Official notice → - 2023-11-01
- US
B. Braun Medical, Inc. recalls 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
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…
FDA · DeviceB. Braun Medical, Inc.Domestic distribution nationwide. Foreign distribution to Canada.Official notice → - 2023-10-04
- US
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 metered dose of a fluid…
The sterile blister packaging may be damaged, and sterility may be compromised
- 2023-09-27
- US
B. Braun Medical, Inc. recalls Perifix¿ / Epidural anesthesia set, medicated
Product may be mislabeled with an incorrect lid stock label.
FDA · DeviceB. Braun Medical, Inc.US Distributions to states of - AR, AZ, CA, FL, GA, IL, MA, MO, NC, NJ, PA,…Official notice → - 2023-08-16
- US
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, NDC 0264-5802-00
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
- 2023-07-19
- US
B. Braun Medical Inc. recalls 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC…
Lack of assurance of sterility: bags have the potential to leak.
- 2023-07-05
- US
B. Braun Medical, Inc. recalls Design Options¿ / Epidural anesthesia kit (10 count carton)
Kits were assembled with the incorrect Filter Straw.
- 2023-05-24
- US
- 2023-03-15
- US
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.Braun Medical Inc,…
Subpotent Drug: low Anti-Factor IIa potency.
- 2023-03-01
- US
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, NDC 0264-5802-10
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…
- 2022-12-14
- US
B. Braun Medical, Inc. recalls 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524…
Lack of sterility assurance: Bags have the potential to leak.
- 2022-10-26
- US
B. Braun Medical, Inc. recalls CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the…
The extension set has a high probability of potential failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of…
FDA · DeviceB. Braun Medical, Inc.Distribution US nationwide, Canada and Saudi Arabia.Official notice → - US
B. Braun Medical, Inc. recalls ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and…
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 delay of therapy, increased risk of bloodstream…
FDA · DeviceB. Braun Medical, Inc.Distribution US nationwide, Canada and Saudi Arabia.Official notice → - 2022-10-12
- US
B Braun Medical Inc recalls Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Potential for leakage at the catheter hub.
FDA · DeviceB Braun Medical IncDomestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign…Official notice → - 2022-04-20
- US
B Braun Medical Inc recalls Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number…
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 excessive ultrafiltration or insufficient ultrafiltration…
- 2022-03-30
- US
B Braun Medical Inc recalls PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog…
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 that can result in delays in therapy,…
- 2022-03-23
- US
B. Braun Medical, Inc. recalls 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
Lack of sterility assurance: leaking bags
- 2022-03-16
- US
B. Braun Medical, Inc. recalls Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of…
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 medication delivered to the patient, cause delays…
FDA · DeviceB. Braun Medical, Inc.US Nationwide distribution in the states of AZ, CA, FL, LA, MI, MO, MS, NC,…Official notice → - 2021-10-06
- US
B. Braun Medical, Inc. recalls PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of…
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 bloodstream infections.
FDA · DeviceB. Braun Medical, Inc.Worldwide distribution - US Nationwide distribution and the country of Canada.Official notice →