Manufacturer

B Braun Medical Inc

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

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.

26–50 of 173

HighFDA (Devices)·Z-0650-2026·2025-12-03
IV Administration Sets Pose Medication Backflow and Occlusion Risk
B Braun Medical Inc is recalling 6,650 IV Administration Sets due to potential backflow of medication into primary containers and inability to prime. The issue could compromise medication delivery in patients.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD SET CARESITE 127 IN.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0677-2026·2025-12-03
IV Administration Set Recalled for Medication Backflow and Occlusion Risk
B Braun Medical Inc is recalling 5,952 IV Administration Sets due to a potential malfunction that could allow medication to flow backward into primary containers and prevent proper priming.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. 15DR 2SAFELINE 1CARESITE 1S
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0674-2026·2025-12-03
IV Administration Set Recalled for Potential Medication Backflow and Priming Issues
B Braun Medical Inc is recalling IV Administration Sets due to potential backflow of medication from secondary to primary IV containers and inability to prime. No illnesses have been reported.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMINISTRATION SET WITH
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0613-2026·2025-12-03
B Braun Anesthesia IV Sets Recalled Due to Backflow and Occlusion
B Braun Medical Inc is recalling 19,320 Anesthesia IV Sets due to potential backflow of medication and inability to prime. The defect affects sets used with specific B Braun infusion pumps in anesthesia.
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 2-HIGH FLOW STPCK
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0608-2026·2025-12-03
B Braun IV Administration Sets Recalled for Medication Backflow Risk
B Braun Medical Inc is recalling 14,712 Anesthesia IV Sets due to potential backflow of medication and priming failure that could affect medication delivery.
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD. SET,15 DROPS/ML, W/EXT S
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0716-2026·2025-12-03
IV Administration Sets Recalled for Potential Medication Backflow and Occlusion
B Braun Medical Inc is recalling Outlook IV administration sets due to potential backflow of medication from secondary to primary IV containers and inability to prime. No illnesses reported.
Product
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DR W/2 CARESITE FILT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0668-2026·2025-12-03
IV Administration Sets: Risk of Medication Backflow and Priming Failure
B Braun Medical Inc recalls IV Administration Sets due to potential medication backflow from secondary into primary containers and priming failure. Worldwide distribution to US, Canada, Germany, Guatemala, and Singapore.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0626-2026·2025-12-03
IV Administration Set Component Recalled for Potential Medication Backflow
B Braun Medical Inc is recalling IV administration set components that may allow medication to flow backward from secondary containers or prevent proper priming. The recall affects approximately 381,850 units distributed worldwide.
Product
Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Primary Gravity Filtered Set with 2 CARE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0657-2026·2025-12-03
B Braun IV Administration Sets Recalled for Potential Medication Backflow
B Braun Medical Inc is recalling 224,856 IV Administration Sets due to potential medication backflow from secondary IV containers into primary containers and inability to prime the line. The sets are used with Infusomat Space, Outlook, and Vista Basic pumps.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 15 DROPS/ML
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0606-2026·2025-12-03
FDA Recalls Anesthesia IV Sets Over Medication Backflow and Occlusion Risk
B Braun Medical is recalling 32,436 Anesthesia IV Sets used with multiple infusion pumps due to potential backflow of medication from secondary containers and inability to prime. No illnesses or injuries have been reported.
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 108
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0635-2026·2025-12-03
B Braun IV Extension Set Recalled for Medication Backflow and Occlusion Risk
B Braun Medical Inc is recalling 27,480 Extension Sets used in gravity and pump IV administration systems. The sets may allow medication to backflow from secondary containers into primary containers or fail to prime correctly.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXT SET ULTRAPORT STOPCOCK, 37IN.;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0690-2026·2025-12-03
IV Administration Set Recalled for Medication Backflow and Priming Failure
B Braun Medical Inc is recalling IV administration sets (Catalog 490303) due to potential backflow of medication into primary IV containers and inability to prime. Approximately 32,304 units were distributed worldwide.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET,3 CARESITE LAD
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0710-2026·2025-12-03
RATE FLOW IV Administration Sets Recalled for Medication Backflow Risk
B Braun Medical Inc is recalling RATE FLOW IV administration sets due to potential medication backflow between IV containers and inability to prime. Approximately 150,664 units affected worldwide.
Product
RATE FLOW set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. RATEFLOW ADMIN 15 DROP W/2 CARESITE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0641-2026·2025-12-03
IV Administration Set Recalled Due to Medication Backflow and Occlusion Risk
B Braun Medical Inc is recalling IV administration sets due to potential medication backflow from secondary IV containers into primary IV containers and inability to prime. 98,688 units have been distributed worldwide.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 10 DROPS/ML
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0620-2026·2025-12-03
Blood Administration Set Recalled Due to Backflow and Occlusion Risk
B Braun Medical Inc is recalling blood administration sets due to potential backflow of medication from secondary IV containers into primary containers, and inability to prime. No illnesses have been reported.
Product
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET W/ 170¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0704-2026·2025-12-03
IV Administration Set Recalled Due to Potential Medication Backflow and Occlusion
B Braun Medical Inc recalls 122,232 IV Administration Sets due to potential medication backflow from secondary containers into primary containers and inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 129 IN, 3 CAR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0652-2026·2025-12-03
B Braun IV Administration Sets: Medication Backflow and Priming Failure
B Braun Medical Inc is recalling 66,792 IV Administration Sets due to potential backflow of medication and inability to prime. The Class II recall affects gravity and pump delivery systems.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET HF STOPCOCK,10
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0631-2026·2025-12-03
Extension Set Recalled for Medication Backflow and Priming Failure
B Braun Medical's Extension Sets may allow medication backflow between IV containers and fail to prime. The company recalled 13,128 units distributed worldwide.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXTENSION SET, 25 IN.; Catalog Numb
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0717-2026·2025-12-03
IV Administration Set Recalled for Potential Medication Backflow and Priming Failure
B Braun Medical's IV Administration Sets may allow medication to flow backward from secondary to primary containers and fail to prime. The malfunction could affect medication delivery accuracy in healthcare facilities.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 15DROPS/ML;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0663-2026·2025-12-03
B. Braun IV Administration Sets Risk Backflow and Occlusion
B. Braun Medical Inc is recalling IV Administration Sets due to potential backflow of medication and inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/CARESITE EXT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0682-2026·2025-12-03
IV Administration Sets Recalled Due to Medication Backflow Risk
B Braun Medical is recalling IV Administration Sets due to potential medication backflow from secondary containers into primary containers and inability to prime the line. Approximately 187,464 units are affected worldwide.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0630-2026·2025-12-03
B. Braun Medical Extension Sets: Risk of IV Medication Backflow and Occlusion
B. Braun Medical extension sets used in IV administration may allow medication backflow from secondary containers into primary containers or fail to prime, potentially compromising treatment delivery. Approximately 43,452 units affected worldwide.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. EXTENSION SET, 18 IN; Catalog Numb
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0638-2026·2025-12-03
Extension Set Recall: Risk of Backflow in IV Administration Sets
B. Braun Medical Inc is recalling 32,500 Extension Sets used in IV administration due to potential backflow of medication and inability to prime the infusion lines.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Caresite Extension Set_Export; Cata
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0619-2026·2025-12-03
Blood Administration Set Recall Due to Backflow and Priming Issues
B Braun Medical Inc is recalling 164,568 Blood Administration Sets due to potential backflow of medication from secondary IV containers into primary containers and inability to prime. The affected sets are used in gravity and pump-based IV administration systems.
Product
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET, HAND P
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0671-2026·2025-12-03
IV Administration Set Recalled for Medication Backflow and Occlusion Risk
B. Braun Medical Inc is recalling IV Administration Sets due to potential backflow of medication from secondary IV containers into primary containers and inability to prime. The defect affects 12,168 units distributed worldwide.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 15 DROPS/ML
Category
Medical Device
Distribution
0 states