B. Braun Medical, Inc.

Complete recall history across all FDA and CPSC categories — 216 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 (2)

FDA drug safety enforcement actions by B. Braun Medical, Inc.

Date Product Reason Class
Nov 25, 2022 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC ... Lack of sterility assurance: Bags have the potential to leak. Class II
Feb 25, 2022 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun... Lack of sterility assurance: leaking bags Class II

Device Recalls (214)

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

Date Product Reason Class
Dec 4, 2024 Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of... Incorrect catheter connector within the kit resulting in inability to provide... Class II
Aug 8, 2024 AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifo... Potential for product leakage from the Spin Lock Connector on the distal end ... Class II
Jun 17, 2024 Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-power... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-p... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-p... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered in... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-pow... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered ... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-po... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electricall... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-p... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powere... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-po... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-pow... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-p... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infu... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infus... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-pow... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-p... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jun 17, 2024 OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered in... Potential for the backcheck valve to malfunction, resulting in backflow of me... Class II
Jan 22, 2024 Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. S... Kits should contain Filter Straws with Standard Luer Connections however the ... Class II
Jan 22, 2024 Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Loc... Kits should contain Filter Straws with Standard Luer Connections however, the... Class II
Nov 1, 2023 Infusomat Administration Sets as listed below: 362031 Infusomat Space Pu... In affected products, the tubing outer diameter may vary in size or the lengt... Class I
Sep 26, 2023 BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration com... Devices may leak as a result of a manufacturing issue. Leakage may result in ... Class II
Sep 26, 2023 SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use. Devices may leak as a result of a manufacturing issue. Leakage may result in ... Class II
Sep 26, 2023 FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids bet... Devices may leak as a result of a manufacturing issue. Leakage may result in ... Class II
Sep 26, 2023 ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation. Devices may leak as a result of a manufacturing issue. Leakage may result in ... Class II
Sep 26, 2023 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast... Devices may leak as a result of a manufacturing issue. Leakage may result in ... Class II
Sep 26, 2023 AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic... Devices may leak as a result of a manufacturing issue. Leakage may result in ... Class II
Sep 26, 2023 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast manageme... Devices may leak as a result of a manufacturing issue. Leakage may result in ... Class II
Sep 26, 2023 THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use ... Devices may leak as a result of a manufacturing issue. Leakage may result in ... Class II
Sep 26, 2023 TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only.... Devices may leak as a result of a manufacturing issue. Leakage may result in ... Class II
Sep 21, 2023 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric ... Upstream occlusion alarm may sound when no occlusion exists, and the device w... Class I
Sep 21, 2023 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System Upstream occlusion alarm may sound when no occlusion exists, and the device w... Class I
Aug 7, 2023 B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (... The sterile blister packaging may be damaged, and sterility may be compromised Class II
Aug 7, 2023 B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deli... The sterile blister packaging may be damaged, and sterility may be compromised Class II
Jul 31, 2023 Perifix¿ / Epidural anesthesia set, medicated Product may be mislabeled with an incorrect lid stock label. Class II
Jun 5, 2023 Perifix¿ / Epidural anesthesia kit (10 count carton) Kits were assembled with the incorrect Filter Straw. Class II
Jun 5, 2023 Design Options¿ / Epidural anesthesia kit (10 count carton) Kits were assembled with the incorrect Filter Straw. Class II

View all 214 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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