Manufacturer

B. Braun Medical, Inc.

446 recalls in our database name B. Braun Medical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 446
Critical: 9
Severe: 40
Most recent: 2026-09-09

Of the 446 recalls from B. Braun Medical, Inc. we have scored against our rubric, 9 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 40 (9%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

251–275 of 446

HighFDA (Devices)·Z-0819-2022·2022-03-30
Infusion Pump Risk of Malfunction in B. Braun Perfusor Space Devices
B. Braun is recalling 6 Perfusor Space infusion pump units that may not function properly due to inadequate inspection, potentially causing incorrect medication dosing and therapy delays.
Product
PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
Category
Medical Device
Distribution
2 states
SevereFDA (Drugs)·D-0655-2022·2022-03-23
B. Braun 0.9% Sodium Chloride Injection bags recalled for leaking
B. Braun Medical, Inc. is recalling 33,742 bags of 0.9% Sodium Chloride Injection USP due to leaking that compromises sterility assurance. The intravenous medication was distributed nationwide.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0727-2022·2022-03-16
B. Braun dispensing pins recalled for air filter leakage risk
B. Braun Medical is recalling dispensing pins with an elevated leakage risk in the air inlet filter. The leakage may reduce medication doses, delay treatment, or contaminate the fluid path, potentially causing bloodstream infection.
Product
Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2552-2021·2021-10-06
B. Braun Outlook IV Pump Sets Recalled Due to Leakage Risk
B. Braun Medical is recalling Outlook pump IV sets used with specific infusion pumps due to leakage in the cassette portion. The defect may prevent proper medication delivery and pose a risk of bloodstream infection.
Product
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 fluids Ref: 474004
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2550-2021·2021-10-06
Outlook pump extension sets recalled due to leakage and dosing errors
Outlook infusion pump extension sets may leak, potentially delaying medication delivery and causing bloodstream infections.
Product
ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470024
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2558-2021·2021-10-06
Outlook Pump Add-On Set Recalled for Potential Leakage and Under-Delivery
B. Braun Medical is recalling the Outlook Pump Add-On Set due to potential leakage that may delay medication delivery and cause incomplete dosing. The affected units could increase the risk of bloodstream infections.
Product
Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7400
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2547-2021·2021-10-06
B. Braun Infusion Pump Sets Recalled Due to Cassette Leakage Risk
B. Braun Medical is recalling 1,960 infusion pump sets used with Outlook Safety and Horizon NXT systems due to leakage in the cassette portion, which may delay medication delivery and increase bloodstream infection risk.
Product
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 of parenteral fluids Ref: 354215
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2554-2021·2021-10-06
Outlook Pump IV Set Recalled Due to Cassette Leakage and Infection Risk
B. Braun Medical is recalling Outlook Pump IV Sets due to cassette leakage that may delay medication delivery and cause incomplete dosing or bloodstream infections.
Product
OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477009
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2553-2021·2021-10-06
B. Braun Outlook Pump Set Recall: Risk of Leakage and Medication Under-Delivery
B. Braun is recalling 1,752 Y-Type Blood Outlook Pump Set units due to leakage in the cassette portion. The defect may cause delays in medication administration, incomplete dosing, or bloodstream infections.
Product
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 parenteral fluids Ref: 477005
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2557-2021·2021-10-06
B. Braun Outlook Pump Set 3 Recalled for Leakage and Medication Delivery Delays
B. Braun Medical is recalling 768 units of Outlook Pump Set 3 infusion sets due to potential leakage that could delay or prevent complete medication delivery and increase risk of bloodstream infection.
Product
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 parenteral fluids Ref: 490564
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2548-2021·2021-10-06
Infusion Pump Sets Recalled for Leakage and Medication Under-Delivery Risk
B. Braun Medical is recalling infusion pump sets that may leak, potentially causing delayed medication delivery, incomplete dosing, and bloodstream infections.
Product
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 parenteral fluids Ref: 354216
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2559-2021·2021-10-06
Outlook Pump Primary Administration Set Recalled for Potential Leakage and Medication Underdosing
B. Braun Medical is recalling the Outlook Pump Primary Administration Set due to potential leakage that could delay medication delivery and cause incomplete dosing of critical fluids in epidural administration.
Product
Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7453
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2560-2021·2021-10-06
Blood Administration Pump Set Recalled Due to Leakage Risk
B. Braun Medical is recalling Outlook Pump Blood Administration Sets due to leakage in the pump cassette that could delay or prevent complete medication delivery and increase infection risk.
Product
Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: NF3120
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2555-2021·2021-10-06
B. Braun Pump Set Cassette Leakage Risks Medication Delivery
B. Braun Medical recalls 13,320 pump sets due to cassette leakage that may delay medication administration and cause incomplete dosing or bloodstream infections.
Product
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 fluids Ref: 480239
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2545-2021·2021-10-06
B. Braun Outlook Pump Sets recalled for potential leakage and infection risk
B. Braun is recalling 585,576 Outlook Pump Sets due to potential leakage in the cassette portion. The defect may cause medication under-delivery and increase bloodstream infection risk.
Product
Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Material ID: 352413
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2544-2021·2021-10-06
B. Braun Infusion Pump Sets Recalled for Leakage and Infection Risk
B. Braun Medical's infusion pump sets may leak, potentially delaying medication delivery and causing incomplete dosing. The defect poses a risk of bloodstream infections.
Product
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 parenteral fluid Material ID: 354212
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2546-2021·2021-10-06
Outlook Pump IV Sets Recalled for Leakage and Infection Risk
B. Braun Medical, Inc. is recalling approximately 44,866 Outlook Pump IV sets due to leakage of the pump set that could delay medication administration and increase the risk of bloodstream infections. The defect may result in under-delivery or incomplete medication dosing.
Product
Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354214
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2556-2021·2021-10-06
Outlook Pump Set Infusion System Recalled for Leakage and Medication Delivery Risk
B. Braun is recalling 7,248 units of Outlook Pump Set that may leak or fail to deliver medications properly, potentially causing bloodstream infections.
Product
OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490361
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2551-2021·2021-10-06
Outlook V1500HP Pump Set Recalled for Cassette Leakage
The Outlook V1500HP Pump Set is recalled due to cassette leakage that could delay medication delivery, reduce dosing accuracy, and cause bloodstream infections. The recall involves 12,000 units distributed in the US and Canada.
Product
V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470025
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2549-2021·2021-10-06
Outlook Pump Measured Volume Solution Set recalled for cassette leakage
B. Braun is recalling 940 units of Outlook Pump Measured Volume Solution Sets due to potential leakage in the cassette. The leakage could delay medication delivery, result in incomplete dosing, or lead to bloodstream infections.
Product
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 infusion of parenteral fluids Ref: 375118
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2137-2021·2021-08-04
Infusomat Space Pump Administration Set Recalled for Inverted Anti-Free Flow Clip
B. Braun Medical is recalling the Infusomat Space Volumetric Pump Administration Set due to a defect where the anti-free flow clip may be inverted, potentially causing unintended medication flow. No injuries have been reported.
Product
Infusomat Space Volumetric Pump Administration Set, Product Code 490100
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1509-2021·2021-05-05
B. Braun Recalls Filtered Triple-Leg Extension Sets Due to Occlusion Risk
B. Braun Medical is recalling 1,900 Filtered Triple-Leg Extension Sets because they may become occluded or unable to prime.
Product
Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0719-2021·2020-12-30
B Braun APEX Compounding System Control Panel Module Recalled
B Braun Medical is recalling 16 APEX Compounding System Control Panel Modules because they may fail to detect air bubbles, potentially compromising drug accuracy.
Product
APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0718-2021·2020-12-30
B Braun APEX Compounding System Control Panel Module Recalled
B Braun Medical is recalling 85 APEX Compounding System Control Panel Modules because they may fail to detect air bubbles, potentially resulting in inaccurate drug compounding.
Product
APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0717-2021·2020-12-30
B Braun APEX Compounding System Control Panel Module Recalled for Accuracy Issues
B Braun Medical is recalling 248 APEX Compounding System Control Panel Modules because they may fail to detect air bubbles, potentially resulting in inaccurate drug compounding.
Product
APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
Category
Medical Device
Distribution
Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

B Braun Medical (United States)

company in Bethlehem, United States

Country: United States
Founded: 1839

Official website

Source: Wikidata (Q30264023), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.