PlainRecalls

B. Braun Medical Inc

309 recalls on record · Latest: Mar 11, 2026

B. Braun Medical Inc Recall Insight

B. Braun Medical Inc appears on 309 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.368% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Mar 11, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 19 critical, 31 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 3 distinct product categories, with issuing agencies dominated by FDA Devices (34), FDA Drug (16). The date window on this page runs from Feb 12, 2014 to Oct 10, 2018.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Oct 10, 2018

CE17TFC CONTINUOUS EPID SET W/17G TUOHY, Material Number 332238 Connection device used by physicians to provide various anesthetic and fluid admi…

FDA Devices Moderate Oct 10, 2018

CE18TK ACCU-BLOC PERIFIX KIT, Material Number 332220 Connection device used by physicians to provide various anesthetic and fluid administration …

FDA Devices Moderate Oct 10, 2018

CE18H CONT EPIDURAL SET, Material Number 332210 Connection device used by physicians to provide various anesthetic and fluid administration devic…

FDA Devices Moderate Oct 10, 2018

ES1725K SPINAL/EPIDURAL TRAY, Material Number 333165 Connection device used by physicians to provide various anesthetic and fluid administration …

FDA Devices Moderate Oct 10, 2018

GOVCE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332602 Connection device used by physicians to provide various anesthetic and fluid admi…

FDA Devices Moderate Oct 10, 2018

CE18HB CONT EPIDURAL HUSTEAD, Material Number 332223 Connection device used by physicians to provide various anesthetic and fluid administration …

FDA Devices Moderate Oct 10, 2018

EC20CST 20G CLSD SOFT TIP CATH, Material Number 333521 Connection device used by physicians to provide various anesthetic and fluid administratio…

FDA Devices Moderate Oct 10, 2018

NES1727KFX W /17GA TUOHY 19GA SPRW OT, Material Number 333197 Connection device used by physicians to provide various anesthetic and fluid admini…

FDA Devices Moderate Oct 10, 2018

CONTIPLEX TUOHY SET, 18GX4", 1.3X100MM, Material Number 331693 Connection device used by physicians to provide various anesthetic and fluid admin…

FDA Devices Moderate Oct 10, 2018

CE18TKST CONT EPID W/SOFT TIP, Material Number 332081 Connection device used by physicians to provide various anesthetic and fluid administration…

FDA Devices Moderate Oct 10, 2018

CNB400TKU NON-STIM CATH FULL KIT, Material Number 332128 Connection device used by physicians to provide various anesthetic and fluid administrat…

FDA Devices Moderate Jul 11, 2018

26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550

FDA Devices Moderate Jul 4, 2018

Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with…

FDA Drug Moderate Mar 7, 2018

0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-0…

FDA Devices Moderate Feb 21, 2018

Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local anesthesia of the skin prior to insertion of the regional anesthesia nee…

FDA Devices Moderate Feb 21, 2018

Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regi…

FDA Devices Moderate Feb 21, 2018

Perifix Epidural AnesthesiaTray. Product Catalog Numbers: 551879, 551994, 552024. Local anesthesia of the skin prior to insertion of the regional…

FDA Devices Moderate Feb 21, 2018

PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

FDA Devices Moderate Feb 21, 2018

Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. Local anesthesia of the skin prior to insertion of the regional ane…

FDA Devices Moderate Feb 21, 2018

Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051, 552083, 552119, 555569. Local anesthesia of the skin prior to inser…

FDA Drug Moderate Dec 27, 2017

0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10

FDA Devices Moderate May 31, 2017

CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)

FDA Devices Moderate Dec 7, 2016

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

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…

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.…

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 impleme…

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 fo…

FDA Devices Critical May 11, 2016

Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatmen…

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 im…

FDA Devices Critical May 11, 2016

Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatm…

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 …

FDA Devices Moderate Sep 24, 2014

B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutan…

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…

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 Do…

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…

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 92614-5…

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 …

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., Irvin…

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 …

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, Sin…

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…

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 containe…

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 9261…

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 …

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'…

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, S…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds