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.

101–125 of 173

HighFDA (Devices)·Z-0655-2026·2025-12-03
IV Administration Set Poses Risk of Medication Backflow and Delivery Obstruction
B Braun Medical Inc is recalling 80,650 IV administration sets due to potential backflow of medication from secondary to primary IV containers and inability to prime. 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 SET W/2 CARESITE & 2 ULT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0609-2026·2025-12-03
IV Administration Sets Recalled for Backflow and Occlusion Risk
B Braun Medical Inc is recalling IV administration sets due to potential backflow of medication between containers and inability to prime the line, which could affect medication delivery in clinical settings.
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, 134
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0660-2026·2025-12-03
IV Administration Set Recalled for Potential Medication Backflow
B Braun Medical Inc is recalling 1,272 units of IV Administration Sets due to potential backflow of medication from secondary containers into primary containers and inability to prime. No illnesses or 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,2 CARESITE, TR
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-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
HighFDA (Devices)·Z-0691-2026·2025-12-03
B. Braun IV Administration Sets Recalled for Medication Backflow Risk
B. Braun Medical Inc is recalling 24,072 IV administration sets used with multiple 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. IV ADMIN SET, 2 CARESITES,
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-0649-2026·2025-12-03
B. Braun IV Administration Sets recalled due to medication backflow risk
B. Braun IV Administration Sets used with multiple infusion pumps are being recalled due to potential for medication backflow from secondary into 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 DR / mL W
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0702-2026·2025-12-03
IV Administration Sets Recalled Due to Backflow and Occlusion Risk
B Braun Medical is recalling IV Administration Sets due to a risk of medication backflow from secondary to primary IV containers and inability to prime. Affected catalog numbers 477002 and 477017 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, 15DR, CARESIT
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-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-0637-2026·2025-12-03
Extension Set Recall: Risk of Medication Backflow in IV Administration
B Braun Medical is recalling 61,423 extension sets used with IV pumps due to potential backflow of medication and inability to prime. The recalled sets are 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 numbers: 1. ANESTHESIA SET W/ SAFEPORT MANIFOL
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0676-2026·2025-12-03
IV Administration Set Recalled for Medication Backflow and Priming Issues
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 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-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-0616-2026·2025-12-03
Blood Administration Set Recall Due to Backflow and Occlusion Risk
B Braun Medical Inc is recalling Blood Administration Sets (catalog 490196) due to potential backflow of medication between IV containers and inability to prime. The recall affects 7,344 units distributed worldwide.
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 124 IN.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0659-2026·2025-12-03
IV Administration Sets Recalled for Potential Medication Backflow and Occlusion
B Braun Medical Inc recalls IV administration sets used with its infusion pumps due to potential backflow of medication into primary IV 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 60 DROP/ML, 10
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0670-2026·2025-12-03
IV Administration Sets Recalled for Medication Backflow and Priming Failure Risk
B Braun Medical IV administration sets carry risk of medication backflow into primary containers and inability to prime. Affects approximately 20.7 million 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 DR W/2 SAFE
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-0632-2026·2025-12-03
IV Administration Extension Set Recalled Due to Medication Backflow Risk
B Braun Medical is recalling 13,600 extension sets used in IV administration systems due to potential backflow of medication and inability to prime. The affected product may cause medication to flow back into primary containers.
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 W/ B/C VLV, ULTRAPORT, 57 I
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-0639-2026·2025-12-03
Extension Sets Recalled by B Braun for Medication Backflow Risk
B Braun Medical Inc is recalling 300 units of extension sets used in IV administration with certain pumps due to potential for medication backflow and inability to prime.
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/2INJ/FLBL/FML LRLK/CV 34; Catal
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-0712-2026·2025-12-03
IV Administration Sets Recalled for Medication Backflow and Occlusion Risk
B Braun Medical Inc is recalling 554,015 units of SafeDAY IV administration sets due to potential medication backflow from secondary containers into primary containers and inability to prime the IV line.
Product
SafeDAY 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 SET 15 DR W/2 SAFEDAY & STOPCO
Category
Medical Device
Distribution
0 states