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B Braun Medical Inc

B Braun Medical Inc Recalls

All product recalls associated with B Braun Medical Inc.

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Recall Summary

Total Recalls

226

Past Year

Class I (Serious)

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 61–80 of 226 recalls

B Braun Medical Inc: Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number...

The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

FDAMay 17, 2024Nationwide• B Braun Medical Inc

Lactated Ringer's Injection (B. Braun) – Potential Sterility Leak (2024)

Lack of assurance of sterility: bags have the potential to leak..

Class IIModerate

FDAMar 22, 2024Nationwide• B. Braun Medical Inc

Potassium Chloride Injection (B. Braun) – sterility risk (2024)

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.

Class II

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Page 4 of 12Next

Moderate

FDAMar 6, 2024Nationwide• B. Braun Medical Inc

B. Braun Medical, Inc.: Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy,...

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.

FDAJan 22, 2024Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: Infusomat Administration Sets as listed below: 362031 I...

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.

FDANov 1, 2023Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. I...

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.

FDASep 26, 2023Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in...

FDASep 26, 2023Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3...

FDASep 26, 2023Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: FT1000S FLUID TRANSFER SET, REF No. 356048. For direct tr...

FDASep 26, 2023Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. ...

FDASep 26, 2023Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for in...

FDASep 26, 2023Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970....

FDASep 26, 2023Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191...

FDASep 26, 2023Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue e...

FDASep 26, 2023Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTE...

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.

FDASep 21, 2023Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: 8713051U, Infusomat Large Volume Pump, Wireless; Volumetr...

FDASep 21, 2023Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to ...

The sterile blister packaging may be damaged, and sterility may be compromised

FDAAug 7, 2023Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intende...

The sterile blister packaging may be damaged, and sterility may be compromised

FDAAug 7, 2023Nationwide• B. Braun Medical, Inc.

Sodium Chloride Injection (B. Braun) – Incomplete Labeling (2023)

Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.

Class IIILow

FDAAug 2, 2023Nationwide• B. Braun Medical Inc.

B. Braun Medical, Inc.: Perifix / Epidural anesthesia set, medicated

Product may be mislabeled with an incorrect lid stock label.

FDAJul 31, 2023AZ, AR, CA +10 more• B. Braun Medical, Inc.