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B Braun Medical Inc

444 recalls on record · Latest: Jun 10, 2026

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Agency notice ledger

Federal filing book B Braun Medical Inc HEAVY-BOOK · MULTI-AGENCY

#18 of 14,151 · 444 notices · 0.425% archive

  • BOOK 444 notices
  • RANK #18 of 14,151
  • SHARE 0.425% archive
  • AGENCY FDA Devices (401)
  • CAT medical devices
  • CATS 2 categories
  • LATEST Jun 10, 2026
  • PHOTO Zimmer, Inc.

Nearest notice-volume peer: Zimmer, Inc. (2 notice gap)

B Braun Medical Inc accounts for about 0.425% of the 104,423-notice archive on 444 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How B Braun Medical Inc compares to 14,151 recalling firms

B Braun Medical Inc ranks 18th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

B Braun Medical Inc vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

444 18th of 14151 higher than 14,133 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-14

B Braun Medical Inc in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows B Braun Medical Inc holds about 0.425% of archive notices alongside 444 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026

How the 444 notices break down

Same federal filing book as the hero total — split by issuing agency, no new counts.

FDA Devices Moderate Dec 7, 2016

Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures

FDA Devices Moderate Nov 9, 2016

Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional anesthesia

FDA Drug Critical Oct 19, 2016

5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32

FDA Devices Moderate Jun 8, 2016

Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)

FDA Devices Moderate Jun 8, 2016

Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)

FDA Devices Moderate Jun 1, 2016

WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular ports.

FDA Devices Critical May 11, 2016

Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure

FDA Devices Critical May 11, 2016

Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 203837 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phase

FDA Devices Critical May 11, 2016

Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis a

FDA Devices Critical May 11, 2016

Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of

FDA Devices Critical May 11, 2016

Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis

FDA Devices Critical May 11, 2016

Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafilt

FDA Devices Moderate Oct 28, 2015

Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.

FDA Devices Moderate May 13, 2015

CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural Anesthesia Tray, ESPOCAN Combined Spinal and Epidural Anesthesia Tray, PERIFIX Continuous Epidural Anesthesia Tray, PERIFIX FX Continuous Epidural Tray, PERIFIX One Continuous Epidural Pediatric Tray; Utilization

FDA Devices Moderate Sep 24, 2014

B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.

FDA Devices Moderate Jul 16, 2014

STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches

FDA Devices Moderate Jun 4, 2014

Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia

FDA Drug Critical May 7, 2014

Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-11, For IV Use Only, Single Use, Sterile, Rx Only, B Braun Medical Inc, Irvine CA 92614-5895, NDC 0264-3123-11

FDA Drug Critical May 7, 2014

Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL Container, Catalog Number 3103-11, For IV Use Only, Sterile, Single Dose, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3103-11

FDA Drug Critical May 7, 2014

Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Container, Catalog Number 3193-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3193-11

FDA Drug Critical May 7, 2014

0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, Sterile, Single Dose Container, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-4000-55

FDA Drug Critical May 7, 2014

0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1800-31

FDA Drug Critical May 7, 2014

Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Container, Catalog Number 3105-11, Rx Only, B Braun Medical Inc., Irvine CA 92614, NDC 0264-3105-11

FDA Drug Critical May 7, 2014

TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-9341-55

FDA Drug Critical May 7, 2014

15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy Bulk Package, Not For Direct Infusion, For Intravenous Use, Sterile, Single Dose Container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-3200-55

FDA Drug Critical May 7, 2014

ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1915-07

FDA Drug Critical May 7, 2014

6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dose container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-9350-55

FDA Drug Critical May 7, 2014

Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Scarborough, Ontario M1H 2W4, NDC 0264-1943-20, Canada DIN 01924311

FDA Drug Critical May 7, 2014

Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog Number 3153-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895

FDA Devices Moderate Feb 26, 2014

SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

FDA Drug Critical Feb 12, 2014

Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11

FDA Devices Moderate Feb 12, 2014

B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.

FDA Drug Moderate Jan 22, 2014

0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, Irvine, CA 92614. NDC 0264-7802-00.

FDA Devices Moderate Jan 1, 2014

B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of vascular access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into vascular system.

FDA Devices Moderate Dec 4, 2013

20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.

FDA Devices Moderate Dec 4, 2013

13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.

FDA Devices Critical Sep 25, 2013

Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-300ES and 621-400ES. To del

FDA Devices Moderate Sep 18, 2013

Outlook Safety Infusion System Burette Set. For intravenous fluid administration.

FDA Devices Moderate Sep 18, 2013

Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300E

FDA Devices Moderate Sep 18, 2013

Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, and 621-200ES. To de

FDA Devices Moderate Sep 18, 2013

Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300E

FDA Devices Moderate May 8, 2013

Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.

FDA Devices Moderate Jan 9, 2013

Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.

FDA Devices Critical Jul 25, 2012

Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.

B Braun Medical Inc carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (444 here — heavy-book).

Similar medical devices volume

Nearest multi-notice firms that share this firm's dominant product category.

Frequently Asked Questions

How many federal recall notices name B Braun Medical Inc?
PlainRecalls indexes 444 distinct federal recall events naming B Braun Medical Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does B Braun Medical Inc sit among other recalling firms?
B Braun Medical Inc ranks #18 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of B Braun Medical Inc's notices?
FDA Devices accounts for 401 of this firm's 444 indexed notices across 2 issuing agencies.
What product category dominates B Braun Medical Inc's filing book?
Filings for B Braun Medical Inc span 2 product categories, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous?
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
B Braun Medical Inc: 444 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming B Braun Medical Inc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026