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 3 critical, 46 moderate, and 1 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 2 distinct product categories, with issuing agencies dominated by FDA Devices (40), FDA Drug (10). The date window on this page runs from Oct 10, 2018 to Nov 1, 2023.

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 Critical Nov 1, 2023

8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System

FDA Devices Moderate Oct 4, 2023

B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the…

FDA Devices Moderate Oct 4, 2023

B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body…

FDA Devices Moderate Sep 27, 2023

Perifix¿ / Epidural anesthesia set, medicated

FDA Drug Low Aug 16, 2023

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00

FDA Drug Moderate Jul 19, 2023

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00

FDA Devices Moderate Jul 5, 2023

Design Options¿ / Epidural anesthesia kit (10 count carton)

FDA Drug Moderate May 24, 2023

Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem…

FDA Drug Moderate Mar 15, 2023

Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, …

FDA Drug Moderate Mar 1, 2023

0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10

FDA Drug Moderate Mar 1, 2023

0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00

FDA Drug Moderate Dec 14, 2022

0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-22…

FDA Devices Moderate Oct 12, 2022

Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.

FDA Devices Moderate Apr 20, 2022

Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. These…

FDA Devices Moderate Apr 20, 2022

Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These…

FDA Drug Moderate Mar 23, 2022

0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20

FDA Devices Moderate Mar 16, 2022

Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication …

FDA Devices Moderate Oct 6, 2021

PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral flu…

FDA Devices Moderate Oct 6, 2021

Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for i…

FDA Devices Moderate Oct 6, 2021

15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of…

FDA Devices Moderate Oct 6, 2021

Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion System and/o…

FDA Devices Moderate Oct 6, 2021

OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenter…

FDA Devices Moderate Oct 6, 2021

OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral f…

FDA Devices Moderate Oct 6, 2021

Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parentera…

FDA Devices Moderate Oct 6, 2021

60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion…

FDA Devices Moderate Oct 6, 2021

Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pum…

FDA Devices Moderate Oct 6, 2021

ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid…

FDA Devices Moderate Oct 6, 2021

10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of…

FDA Devices Moderate Aug 4, 2021

Infusomat Space Volumetric Pump Administration Set, Product Code 490100

FDA Devices Moderate Dec 30, 2020

APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration to a patien…

FDA Devices Moderate Dec 30, 2020

APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration to a patien…

FDA Devices Moderate Dec 30, 2020

APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patien…

FDA Drug Critical May 6, 2020

Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, N…

FDA Devices Moderate Feb 12, 2020

Y-Type Blood Set, Catalog Number 490425

FDA Devices Moderate Feb 12, 2020

Y-Type Blood Set, Catalog Number 490293

FDA Devices Moderate Feb 12, 2020

Y-Type Blood Set, Catalog Number 490530

FDA Devices Moderate Feb 12, 2020

Y-Type Blood Set, Catalog Number 490314

FDA Devices Moderate Feb 12, 2020

Safeline Y-Type Blood Set, Catalog Number V2500

FDA Devices Critical Oct 2, 2019

B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032

FDA Devices Moderate Sep 11, 2019

CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186

FDA Devices Moderate Sep 11, 2019

ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114

FDA Devices Moderate Sep 11, 2019

CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187

FDA Devices Moderate Sep 11, 2019

CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191

FDA Devices Moderate Sep 11, 2019

CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188

FDA Devices Moderate Sep 11, 2019

CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183

FDA Devices Moderate Sep 11, 2019

CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189

FDA Drug Moderate Jun 19, 2019

Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only, B. Braun Medical Inc…

FDA Devices Moderate Oct 10, 2018

CE17TKFSDTD EPID TRAY W/17GA FIXED WING, Material Number 332095 Connection device used by physicians to provide various anesthetic and fluid admi…

FDA Devices Moderate Oct 10, 2018

CNB200TKU NON-STIM CATH FULL KIT, Material Number 332127 Connection device used by physicians to provide various anesthetic and fluid administrat…

FDA Devices Moderate Oct 10, 2018

CNBFX350O CONTIPLEX CONT NERVE BLOCK, Material Number 331670 Connection device used by physicians to provide various anesthetic and fluid adminis…

Nearby Manufacturers

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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