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.

76–100 of 173

HighFDA (Devices)·Z-0648-2026·2025-12-03
IV Administration Sets Recalled for Backflow Risk and Priming Defect
B. Braun Medical's IV administration sets may allow medication to backflow from secondary containers into primary containers and may be unable to prime. The company is recalling 89,552 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 ANES 15DROP W/2 CARESITE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0706-2026·2025-12-03
Outlook IV Pump Sets Recalled for Medication Backflow and Occlusion Risk
B. Braun Medical is recalling 6,672 Outlook pump sets used in IV administration due to potential backflow of medication from secondary containers into primary ones and inability to prime. No illnesses 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,115
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0707-2026·2025-12-03
Outlook IV Administration Sets Recalled for Backflow and Occlusion Risk
B Braun Medical Inc is recalling Outlook IV administration sets used with multiple infusion pumps due to potential medication backflow from secondary to primary IV containers and inability to prime properly.
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 15DROP W/3 CARESITE; C
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0669-2026·2025-12-03
IV Administration Sets recalled for medication backflow and occlusion risk
B. Braun Medical Inc. is recalling 190,625 IV administration sets due to potential backflow of medication between containers and inability to prime the line. No injuries 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 ADMIN SET 15 DROP W/ CAR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0604-2026·2025-12-03
B Braun IV Administration Sets Recalled for Backflow and Occlusion Risk
B Braun Medical Inc is recalling ADDitIV IV administration sets due to potential backflow of medication from secondary containers into primary containers and inability to prime. Affected units were distributed worldwide including the US, Canada, Germany, Guatemala, and Singapore.
Product
ADDitIV 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. V1782F UNIV IV SET W/0.2 MICRON FILTER; C
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0694-2026·2025-12-03
IV Administration Set Recalled for Potential Medication Backflow and Occlusion Risk
B Braun IV administration sets used with multiple pump models risk medication backflow from secondary into primary IV containers and priming failure. No injuries 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 ADMIN SET 124 IN.; Catal
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0666-2026·2025-12-03
IV Administration Set Recalled for Risk of Medication Backflow and Occlusion
B. Braun Medical is recalling 23,160 IV administration sets used with its infusion pumps 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 W/15 DROPS/ML,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0698-2026·2025-12-03
IV Administration Sets Recalled for Backflow and Occlusion Risk
IV Administration Sets from B Braun Medical may allow medication to backflow from secondary into primary containers and may fail to prime. This FDA Class II recall affects approximately 98,568 units.
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-0703-2026·2025-12-03
IV Administration Sets Recalled for Potential Medication Backflow Risk
B Braun IV administration sets may allow medication backflow from secondary to primary containers and inability to prime. The FDA issued a Class II recall affecting 31,392 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 AD.SET W/15 DR 128 IN, E
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0647-2026·2025-12-03
IV Administration Set Recall Due to Backflow and Priming Occlusion Risk
B Braun Medical's IV administration sets may allow medication backflow into primary containers and prevent proper priming. FDA issued a Class II recall for the affected sets used in multiple pump models.
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 15D, 2 B/C VLV, 3
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0640-2026·2025-12-03
IV Administration Sets Risk Medication Backflow and Pump Occlusion Failure
B Braun Medical Inc is recalling multiple IV administration sets used with gravity and pump infusion systems. The sets pose a risk of medication backflow between containers and inability to prime the pump.
Product
Infusomat 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. UNIV.15DROP PUMP SET W/3 SAFELINE LL;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0675-2026·2025-12-03
IV Administration Set Recalled for Medication Backflow and Priming Issues
B Braun Medical Inc is recalling 65,232 IV Administration Sets used with multiple infusion pump models due to potential backflow of medication 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. Catalog Number: 490549; Pri
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0633-2026·2025-12-03
Extension Set for IV Administration May Allow Medication Backflow
B Braun Medical extension sets used in gravity and pump IV administration may allow medication from secondary containers to flow backward into primary containers, interfering with medication delivery.
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 W/ B/C VALVE 53 in.;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0684-2026·2025-12-03
IV Administration Set Recalled for Backflow and Occlusion Risk
B Braun Medical Inc is recalling IV administration sets due to potential backflow of medication from secondary containers into primary containers and inability to prime. The recall affects 126,050 units with worldwide distribution.
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 ADM 15D 2 CARESITE, SAFE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0618-2026·2025-12-03
Blood Administration Sets: Risk of Medication Backflow and Occlusion
B Braun Medical Inc is recalling Y-type blood administration sets due to potential backflow of medication from secondary IV containers into primary containers, which could also prevent proper priming.
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, 3 CARS
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0642-2026·2025-12-03
B Braun IV Administration Sets recalled for potential medication backflow
B Braun Medical Inc is recalling IV Administration Sets due to potential for medication backflow from secondary to primary containers. The defect may also 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 numbers: 1. IV ADMIN SET, 10 DROPS/ML,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0603-2026·2025-12-03
B Braun ADDitIV IV Administration Sets Recalled for Medication Backflow
B Braun recalled over 43,900 ADDitIV gravity and pump IV administration sets worldwide due to potential medication backflow from secondary bags into primary bags and inability to prime.
Product
ADDitIV 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, 2 Non-Needle-Fre
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0646-2026·2025-12-03
IV Administration Sets Recalled for Medication Backflow and Occlusion Risk
B Braun IV administration sets may allow medication backflow from secondary containers into primary containers or fail to prime. Approximately 1,019 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 SET W/2 CARESITE & 1 ULT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0605-2026·2025-12-03
B Braun ADDitIV IV Administration Sets Recalled for Medication Backflow Risk
B Braun Medical Inc is recalling approximately 12,700 ADDitIV IV administration sets worldwide due to potential backflow of medication from secondary to primary containers and inability to prime.
Product
ADDitIV 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. PB602VSL NON-VENT SET 103-IN-DR; Catalog
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0624-2026·2025-12-03
Caresite IV Administration Sets Recalled Due to Backflow and Occlusion Risk
B Braun Medical Inc is recalling Caresite IV administration sets due to potential backflow of medication from secondary IV lines into primary containers and inability to prime. Over 12 million units are 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-0661-2026·2025-12-03
IV Administration Sets Recalled Due to Backflow and Occlusion Risk
B Braun Medical Inc is recalling IV administration sets used with certain infusion pumps due to potential backflow of medication and inability to prime. Approximately 259,392 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 W/ 2 CARESITE,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0614-2026·2025-12-03
FDA Recalls Anesthesia IV Sets Due to Medication Backflow and Priming Failure
B Braun Medical Inc is recalling approximately 58,752 anesthesia IV sets worldwide due to potential backflow of medication from secondary containers into 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 117 IN.; Catalog N
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0672-2026·2025-12-03
IV Administration Set Backflow and Occlusion Recall by B. Braun
B. Braun Medical is recalling IV administration sets due to potential backflow of medication from secondary to primary containers and inability to prime, affecting 1,080 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 15 DROP, 132 I
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0699-2026·2025-12-03
IV Administration Sets: Potential Medication Backflow and Occlusion
B Braun Medical Inc is recalling IV Administration Sets used with its gravity and pump-based IV systems. The sets may allow medication backflow from secondary containers into primary containers and may fail to prime, affecting about 5,100 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 103 IN.; Catal
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0665-2026·2025-12-03
IV Administration Set Risk of Medication Backflow and Occlusion
B Braun Medical Inc is recalling IV administration sets used with their infusion pumps due to potential backflow of medication 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 15DR, 92 IN W/
Category
Medical Device
Distribution
0 states