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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

263

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 263 recalls

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.: 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...

1...3 456 7...14

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

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

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.: 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTE...

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.

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.: Perifix / 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.: Design Options / Epidural anesthesia kit (10 count carton)

Kits were assembled with the incorrect Filter Straw.

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

2022 BRAUN AMBULANCES EXPRESS PLUS TYPE I Recall: SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:HOSES, LINES/PIPING, AND FITTINGS

Braun Ambulances (Braun) is recalling certain 2019-2023 Chief XL Type I, Express Plus Type I, and Liberty Type I ambulances built on Chevrolet medium and heavy-duty chassis. The Liquid Spring suspension systems may come in direct contact with the right rear brake line, causing excessive wear and possibly resulting in the loss of the rear brakes.

NHTSAMay 9, 2023Nationwide• BRAUN AMBULANCES

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

BRAUN ABILITY TURNY CHILD SEAT WELDMENT Equipment Recall: EQUIPMENT ADAPTIVE/MOBILITY

Braun Corporation (Braun) is recalling certain child seat weldments sold as accessory parts to the BraunAbility Turny Seat, model number 225 and part number TAS-01223. The child restraint lower anchors may have been manufactured with improper welds.

NHTSAFeb 13, 2023Nationwide• BRAUN ABILITY TURNY

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.

2020 BRAUN AMBULANCES PATRIOT Recall: VISIBILITY:DEFROSTER/DEFOGGER/HVAC SYSTEM

Fire/Burn Risk

Braun Ambulances (Braun) is recalling certain 2014-2022 Chief XL, Express, Express Plus, Liberty, Patriot, Signature, Super Chief, and TLC vehicles. Excessive voltage may damage the condenser fan relay, resulting in failure and overheating of the Heating, Ventilation, and Air Conditioning (HVAC) system.

NHTSADec 9, 2022Nationwide• BRAUN AMBULANCES

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.