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.

426–446 of 446

SevereFDA (Drugs)·D-1275-2014·2014-05-07
B. Braun Recalls Hyperlyte CR Injectable Due to Particulate Matter
B. Braun Medical Inc. is recalling Hyperlyte CR injectable products because visible particulate matter was found in reserve sample units.
Product
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1267-2014·2014-05-07
B. Braun Recalls Cefepime Injection Due to Visible Particulate Matter
B. Braun Medical Inc. is recalling Cefepime Hydrochloride and Dextrose injection units because visible particulate matter was found in reserve samples.
Product
CEFEPIME HYDROCHLORIDE AND DEXTROSE — CEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1268-2014·2014-05-07
B. Braun Recalls Cefazolin Sodium Injectable Due to Particulate Matter
B. Braun Medical Inc. is recalling specific lots of Cefazolin Sodium injectable products because visible particulate matter was found in reserve sample units.
Product
CEFAZOLIN SODIUM — CEFAZOLIN SODIUM (CEFAZOLIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1266-2014·2014-05-07
B. Braun Recalls Ceftriaxone Injection Due to Particulate Matter
B. Braun Medical Inc. is recalling Ceftriaxone for Injection and Dextrose Injection due to visible particulate matter found in reserve sample units.
Product
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1271-2014·2014-05-07
B. Braun Recalls FreAmine HBC Injection Due to Particulate Matter
B. Braun Medical Inc. is recalling 6.9% FreAmine HBC (Amino Acid Injection) units due to visible particulate matter found in reserve samples.
Product
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1264-2014·2014-05-07
B. Braun Recalls Cefoxitin and Dextrose Injectable Due to Particulate Matter
B. Braun Medical Inc. is recalling Cefoxitin and Dextrose injectable products due to visible particulate matter found in reserve sample units.
Product
CEFOXITIN AND DEXTROSE — CEFOXITIN AND DEXTROSE (CEFOXITIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0987-2014·2014-02-26
B. Braun Recalls SAFSITE Injection Sites and IV Sets Due to Leakage
B. Braun Medical is recalling specific lots of SAFSITE Injection Sites and IV Sets because complaints reported leakage. The devices are used for needle-free access on IV and extension sets.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1054-2014·2014-02-12
B. Braun Recalls Cefepime Injection Due to Visible Organic Particulate Matter
B. Braun Medical Inc. is recalling 18,936 containers of Cefepime Hydrochloride and Dextrose Injection due to the presence of visible organic particulate matter.
Product
CEFEPIME HYDROCHLORIDE AND DEXTROSE — CEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0921-2014·2014-02-12
B. Braun AccuFlo Elastomeric Infusion Pump Recalled for Flow Rate Issues
B. Braun Medical is recalling AccuFlo Elastomeric Infusion Pumps because internal testing found flow rates outside specifications, which may cause overly rapid medication infusion.
Product
B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.
Category
Medical Device
Distribution
1 state
ModerateFDA (Drugs)·D-407-2014·2014-01-22
B. Braun Recalls Sodium Chloride Injection Due to Incorrect Bar Code Labeling
B. Braun Medical Inc. is recalling 19,572 bags of 0.45% Sodium Chloride Injection because the bar code incorrectly identifies the product as Potassium Chloride.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0559-2014·2014-01-01
B. Braun IV Catheters Recalled for Missing Safety Clip
B. Braun Medical is recalling 55,200 Introcan Safety IV Catheters because one lot may lack the anti-needlestick safety clip.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0424-2014·2013-12-04
B. Braun addEASE Binary Connector Recalled for Possible Solution Leakage
B. Braun Medical is recalling addEASE Binary Connectors because a misaligned needle may cause solution to leak from the PAB bag.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0425-2014·2013-12-04
B. Braun Recalls addEASE Binary Connectors Due to Solution Leakage
B. Braun Medical is recalling 4,000 addEASE Binary Connectors because a misaligned needle may cause solution to leak from the bag stopper.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2188-2013·2013-09-25
B. Braun Outlook ES Infusion Pumps Recalled for Display Error
B. Braun Medical Inc. is recalling Outlook ES pumps because the display may show infusion is active when the pump has actually stopped.
Product
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 con
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2164-2013·2013-09-18
B. Braun Outlook ES Infusion Pumps Recalled for DoseGuard Software Defect
B. Braun Medical Inc. is expanding a field correction for Outlook ES pumps where a specific key sequence can disable dose limit protection.
Product
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 co
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2175-2013·2013-09-18
B. Braun Outlook ES Pumps Recalled for Potential Drug Library Loss
B. Braun Medical is recalling Outlook ES pumps because a software issue could cause the drug library to be lost, potentially leading to incorrect medication dosing.
Product
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 con
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2163-2013·2013-09-18
B. Braun Outlook ES Infusion Pumps Recalled for Key Panel Failure
B. Braun Medical Inc. is recalling Outlook ES Safety Infusion Systems because the HOLD button may fail to function due to intermittent circuitry contact.
Product
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 co
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2166-2013·2013-09-18
B. Braun Recalls Outlook Safety Infusion System Burette Sets
B. Braun Medical is recalling 900 Outlook Safety Infusion System Burette Sets because one injection site and valve were assembled upside down.
Product
Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1183-2013·2013-05-08
B. Braun Recalls Diacap Ultra Dialysis Fluid Filters Due to Moisture Loss
B. Braun Medical is recalling 1,580 Diacap Ultra Dialysis Fluid Filters because residual moisture may reduce over time, lowering membrane permeability.
Product
Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0623-2013·2013-01-09
B. Braun Recalls Infusomat Space Pump Pole Clamps Due to Breakage Risk
B. Braun Medical is recalling 13,078 Infusomat Space Pump Pole Clamps because the locking grids may break.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1992-2012·2012-07-25
B. Braun Infusomat Space Pump Recall for Anti-Free Flow Clip Defect
B. Braun Medical is recalling 38,225 Infusomat Space Pumps because the anti-free flow clip catch may break if the IV set is inserted incorrectly.
Product
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/medica
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.