B. Braun Medical Inc

Complete recall history across all FDA and CPSC categories — 25 total recalls

B. Braun Medical Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (25)

FDA drug safety enforcement actions by B. Braun Medical Inc

Date Product Reason Class
Mar 31, 2025 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL... Presence of Particulate Matter Class II
Jul 24, 2024 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Brau... Presence of Particulate Matter Class I
Mar 22, 2024 Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Me... Lack of assurance of sterility: bags have the potential to leak.. Class II
Mar 6, 2024 Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), ... Lack of assurance of sterility: pinholes, within the blue label characters on... Class II
May 9, 2023 Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dext... Subpotent: Low anti-factor IIa Potency. Class II
Mar 1, 2023 Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dext... Subpotent Drug: low Anti-Factor IIa potency. Class II
Apr 18, 2020 Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Dupl... Failed Stability Specifications: Out-of-Specification (OOS) results for High ... Class I
Jun 13, 2019 Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextr... Subpotent Drug: low out-of-specification results were identified for the drug... Class II
Feb 16, 2018 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PI... Presence of Particulate Matter: Customer complaint of particulate matter whic... Class II
Dec 15, 2017 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), ... Presence of Particulate Matter: identified as polyethylene, which is consiste... Class II
Mar 25, 2016 5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun... Non-Sterility: fungal contamination due to leaking containers. Class I
Nov 27, 2013 0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Bra... Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% ... Class II
Nov 21, 2013 Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Conta... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several in... Class I
Nov 21, 2013 Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, C... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several in... Class I
Nov 21, 2013 6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a ... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several in... Class I
Nov 21, 2013 ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 ... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several in... Class I
Nov 21, 2013 15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy ... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several in... Class I
Nov 21, 2013 TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No.... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several in... Class I
Nov 21, 2013 Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several in... Class I
Nov 21, 2013 0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB C... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several in... Class I
Nov 21, 2013 0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, ... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several in... Class I
Nov 21, 2013 Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL ... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several in... Class I
Nov 21, 2013 Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 m... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several in... Class I
Nov 21, 2013 Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Containe... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several in... Class I
Oct 15, 2013 Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Deliver... Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextro... Class I

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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