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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 81–100 of 226 recalls

Sodium Chloride Injection (B. Braun) – Sterility Leak Risk (2023)

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

Class IIModerate

FDAJul 5, 2023Nationwide• B. Braun Medical Inc.

B. Braun Medical, Inc.: Design Options / Epidural anesthesia kit (10 count carton)

Kits were assembled with the incorrect Filter Straw.

FDAJun 5, 2023Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: Perifix / Epidural anesthesia kit (10 count carton)

Kits were assembled with the incorrect Filter Straw.

FDAJun 5, 2023Nationwide

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• B. Braun Medical, Inc.

Heparin Sodium (B. Braun Medical) – Low Anti-Factor IIa Potency (2023)

Subpotent: Low anti-factor IIa Potency.

Class IIModerate

FDAMay 9, 2023Nationwide• B. Braun Medical Inc

Heparin Sodium (B. Braun) – Low Potency Risk (2023)

Subpotent Drug: low Anti-Factor IIa potency.

Class IIModerate

FDAMar 1, 2023Nationwide• B. Braun Medical Inc

Sodium Chloride Injection 1000ml (B. Braun) – Sterility Concern (2023)

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.

Class IIModerate

FDAFeb 10, 2023Nationwide• B. Braun Medical Inc.

Sodium Chloride Injection 500ml (B. Braun) – Sterility Concern (2023)

Class IIModerate

FDAFeb 10, 2023Nationwide• B. Braun Medical Inc.

Sodium Chloride Injection (B. Braun) – Potential Leakage (2022)

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

Class IIModerate

FDANov 25, 2022FL, NJ, PA• B. Braun Medical, Inc.

B. Braun Medical, Inc.: CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470...

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 bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.

FDASep 15, 2022Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: ULTRASITE US04TL Smallbore T-Port Extension Set, Product ...

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 infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.

FDASep 15, 2022Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470...

FDASep 15, 2022Nationwide• B. Braun Medical, Inc.

B Braun Medical Inc: Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 425189...

Potential for leakage at the catheter hub.

FDASep 1, 2022AZ, CA, FL +12 more• B Braun Medical Inc

Sodium Chloride Injection (B. Braun) – sterility risk (2022)

Lack of sterility assurance: leaking bags

Class IIModerate

FDAFeb 25, 2022Nationwide• B. Braun Medical, Inc.

B Braun Medical Inc: PERFUSOR SPACE - US VERSION. Intended Use: syringe infusi...

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, overinfusion, or underinfusion.

FDAFeb 7, 2022MA, VT• B Braun Medical Inc

B. Braun Medical, Inc.: Dispensing Pins for Air Inlet Filter, Product Catalog No....

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 in treatment due to the need to replace the device or may cause contamination of the fluid path that can lead to bloodstream infection.

FDAJan 31, 2022Nationwide• B. Braun Medical, Inc.

B Braun Medical Inc: Conductivity Sensors utilized on Dialog and Dialog+ Hemod...

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 depending on whether the dialysis machine is equipped with a Dialysis Fluid filter.

FDAJan 28, 2022Nationwide• B Braun Medical Inc

B. Braun Medical, Inc.: 15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single...

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.

FDAAug 10, 2021Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single...

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.

FDAAug 10, 2021Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: Outlook Pump Sets w/3 CARESITE Needle-Free Injection Site...

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.

FDAAug 10, 2021Nationwide• B. Braun Medical, Inc.

B. Braun Medical, Inc.: Outlook Pump Primary Administration Set w/ micro Tubing f...

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.

FDAAug 10, 2021Nationwide• B. Braun Medical, Inc.