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.

51–75 of 173

HighFDA (Devices)·Z-0622-2026·2025-12-03
IV Burette Sets Recalled Due to Potential Medication Backflow Risk
B Braun Medical Inc is recalling 7,240 Burette Sets used in IV administration due to potential medication backflow from secondary containers and inability to prime. The affected catalog number 490159 was distributed worldwide.
Product
Burette 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. BURETTE SET W/ 2 CARESITE, 134 IN.; C
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0625-2026·2025-12-03
IV Administration Sets: Potential Medication Backflow and Occlusion Risk
B Braun Medical's Caresite injection sites in IV administration sets may allow medication to flow backward from secondary containers into primary containers and prevent proper line priming. Approximately 2.8 million units affected 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 numbers: 1. Primary Gravity IV Set with 2 CARESITE¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0714-2026·2025-12-03
B Braun IV Administration Sets Recalled for Medication Backflow Risk
B Braun Medical recalls 41,400 ULTRASITE IV administration sets worldwide due to potential backflow of medication from secondary IV containers and inability to prime.
Product
ULTRASITE 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/ 2 ULTRASITE VLV, 10
Category
Medical Device
Distribution
0 states
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-0696-2026·2025-12-03
B Braun IV Administration Sets Recalled for Backflow and Occlusion Risk
B Braun Medical is recalling 4,536 IV Administration Sets worldwide due to potential backflow of medication from secondary containers into primary containers and inability to prime. This could compromise safe medication delivery.
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-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-0617-2026·2025-12-03
Blood Administration Sets Recalled Due to Medication Backflow and Occlusion Risk
B Braun Medical Inc recalls 24,624 blood administration sets due to potential medication backflow and priming failures. The defect may allow secondary IV medications to flow backward into primary lines, affecting IV therapy delivery.
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-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-0705-2026·2025-12-03
IV Administration Set Risk of Medication Backflow and Occlusion
B. Braun Medical Inc. recalls AESTHESIA IV Administration Sets due to potential backflow of medication from secondary containers into primary containers and inability to prime. Approximately 4,488 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. AESTHESIA IV SET, 127 in.;
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-0628-2026·2025-12-03
B Braun IV Extension Sets Recalled for Potential Medication Backflow
B Braun Medical Inc is recalling 30,250 Extension Sets used with infusion pumps due to potential medication backflow from secondary IV containers into primary containers and inability to prime the line.
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. ET08US EXTENSION SET W/ULTRA Y SITE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0607-2026·2025-12-03
FDA Recalls B Braun IV Administration Sets for Medication Backflow Risk
B Braun Medical Inc recalls 104,784 IV administration sets used with multiple infusion pumps due to potential medication backflow from secondary to primary containers and inability to prime.
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, 132
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0651-2026·2025-12-03
IV Administration Set Recalled for Backflow Risk and Occlusion Issues
B Braun Medical Inc is recalling IV administration sets that may allow medication to flow backward from secondary containers into primary containers and may fail to prime properly.
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 SET 3 CARESITE ULTRA ZER
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0664-2026·2025-12-03
B Braun IV Administration Sets recalled due to medication backflow and occlusion
B Braun is recalling IV administration sets due to potential medication backflow from secondary containers into primary containers and inability to prime. About 11,832 units were distributed worldwide, including the US.
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, 15 DR/ML,2 CA
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0679-2026·2025-12-03
IV Administration Set Recalled for Medication Backflow and Occlusion Risk
B Braun Medical recalls an IV administration set used with gravity and pump infusion systems due to potential backflow of medication into primary IV containers and inability to prime. Approximately 15,250 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. PB1500 15 DROP IV SET W/2 S
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0713-2026·2025-12-03
IV Administration Sets Risk Medication Backflow and Occlusion
B Braun Medical recalls SAFELINE IV administration sets due to potential medication backflow from secondary containers and inability to prime, affecting 46,250 units distributed worldwide.
Product
SAFELINE 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. UNIVERSAL IV ADMIN SET; Catalog Numb
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0643-2026·2025-12-03
IV Administration Set recalled for potential medication backflow and occlusion
B Braun Medical Inc is recalling 13,870 units of the NF1270A SAFELINE ANESTHESIA IV Administration Set worldwide due to potential backflow of medication from secondary IV 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. NF1270A SAFELINE ANESTHESIA
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0645-2026·2025-12-03
IV Administration Sets Recalled for Potential Medication Backflow and Occlusion Risk
B Braun Medical Inc recalls 407,800 IV administration sets for potential backflow of medication and occlusion. The defect may prevent proper medication delivery in gravity and pump administration 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 SET 15DR 5CARESITE 1 ULR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0697-2026·2025-12-03
IV Administration Sets Risk Medication Backflow and Priming Failure
B Braun Medical IV administration sets used with certain infusion pumps may allow medication to flow backward from secondary containers into primary containers and fail to prime. This could result in incorrect medication delivery.
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-0656-2026·2025-12-03
IV Administration Sets Recalled for Medication Backflow Risk
B. Braun Medical Inc is recalling IV Administration Sets used with its infusion pumps due to potential medication backflow from secondary to primary IV containers and inability to prime properly.
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-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
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-0615-2026·2025-12-03
B.Braun IV Administration Sets Recalled for Medication Backflow Risk
B.Braun IV administration sets used with certain infusion pumps are recalled due to potential medication backflow from secondary containers into primary containers and inability to prime. No illnesses reported.
Product
B.BRAUN 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/ 60 DROPS/ML,141 in.; Cata
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0708-2026·2025-12-03
B Braun Medical IV Administration Sets: Medication Backflow and Occlusion Risk
B Braun Medical Inc is recalling approximately 2,352 Outlook IV administration sets due to potential backflow of medication into primary containers and inability to prime. No injuries have been 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 PUMP SET 3 CARESITE LADS 133
Category
Medical Device
Distribution
0 states