PlainRecalls

B. Braun Medical Inc

Compiled from official public sources by the editorial team.

433 recalls on record · Latest: May 13, 2026

B. Braun Medical Inc Recall Insight

B. Braun Medical Inc appears on 433 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.426% 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 May 13, 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 6, 2021 to Jun 19, 2024.

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 Jun 19, 2024

Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260

FDA Devices Moderate Jun 19, 2024

Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502

FDA Devices Moderate Jun 19, 2024

Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278

FDA Drug Moderate Apr 10, 2024

Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00

FDA Drug Moderate Mar 20, 2024

Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 026…

FDA Devices Moderate Feb 28, 2024

Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices intended for the administra…

FDA Devices Moderate Feb 28, 2024

Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)-A c…

FDA Devices Critical Dec 13, 2023

Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming …

FDA Devices Moderate Nov 15, 2023

TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.

FDA Devices Moderate Nov 15, 2023

THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for int…

FDA Devices Moderate Nov 15, 2023

30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.

FDA Devices Moderate Nov 15, 2023

AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.

FDA Devices Moderate Nov 15, 2023

30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.

FDA Devices Moderate Nov 15, 2023

ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.

FDA Devices Moderate Nov 15, 2023

FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.

FDA Devices Moderate Nov 15, 2023

SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.

FDA Devices Moderate Nov 15, 2023

BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.

FDA Devices Critical Nov 1, 2023

8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System

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 Devices Moderate Jul 5, 2023

Perifix¿ / 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 26, 2022

CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, inj…

FDA Devices Moderate Oct 26, 2022

ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets

FDA Devices Moderate Oct 26, 2022

Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection…

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 Devices Moderate Mar 30, 2022

PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 871…

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…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare B. Braun Medical Inc with Zimmer Biomet, Inc. →

Data Sources

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.