B Braun Medical Inc

Complete recall history across all FDA and CPSC categories — 170 total recalls

B Braun Medical Inc appears in recall records across 2 categories. 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 (7)

FDA drug safety enforcement actions by B Braun Medical Inc

Date Product Reason Class
Aug 26, 2025 STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Beth... Lack of Assurance of Sterility- Potential for fluid leakage from the port due... Class II
Aug 26, 2025 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL... Lack of Assurance of Sterility- Potential for fluid leakage from the port due... Class II
Aug 18, 2025 Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medica... Presence of Particulate Matter Class I
Aug 18, 2025 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medi... Presence of Particulate Matter. Class I
Aug 4, 2025 Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Ste... Lack of Assurance of Sterility; potential for fluid leakage at one of the wel... Class II
Aug 4, 2025 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, ... Lack of Assurance of Sterility; potential for fluid leakage at one of the wel... Class II
Jun 16, 2025 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containe... Lack of assurance of sterility: pinholes, within the finger boxes used during... Class II

Device Recalls (163)

FDA medical device enforcement actions by B Braun Medical Inc. Showing most recent 50.

Date Product Reason Class
Feb 2, 2026 Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Mod... The potential for the needle tip to be dull/blunt, difficult to advance, and/... Class II
Feb 2, 2026 Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Ca... The potential for the needle tip to be dull/blunt, difficult to advance, and/... Class II
Feb 2, 2026 Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number... The potential for the needle tip to be dull/blunt, difficult to advance, and/... Class II
Oct 29, 2025 Outlook set utilized in gravity IV administration sets and pump administratio... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 Extension Set utilized in gravity IV administration sets and pump administrat... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 Anesthesia IV Set utilized in gravity IV administration sets and pump adminis... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 B.BRAUN utilized in gravity IV administration sets and pump administration se... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 SafeDAY set utilized in gravity IV administration sets and pump administratio... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 Blood Administration Set utilized in gravity IV administration sets and pump ... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 Extension Set utilized in gravity IV administration sets and pump administrat... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 Burette Set utilized in gravity IV administration sets and pump administratio... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 CARESAFE utilized in gravity IV administration sets and pump administration s... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 ULTRASITE set utilized in gravity IV administration sets and pump administrat... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 Caresite utilized in gravity IV administration sets and pump administration s... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 Outlook set utilized in gravity IV administration sets and pump administratio... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 Anesthesia IV Set utilized in gravity IV administration sets and pump adminis... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 Extension Set utilized in gravity IV administration sets and pump administrat... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 Anesthesia IV Set utilized in gravity IV administration sets and pump adminis... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 Extension Set utilized in gravity IV administration sets and pump administrat... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 Extension Set utilized in gravity IV administration sets and pump administrat... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 Outlook set utilized in gravity IV administration sets and pump administratio... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 Anesthesia IV Set utilized in gravity IV administration sets and pump adminis... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 RATE FLOW set utilized in gravity IV administration sets and pump administrat... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers... Class II

View all 163 device recalls →

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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