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.

76–100 of 446

HighFDA (Devices)·Z-0704-2026·2025-12-03
Infusion sets recalled over backflow from secondary bags into primary
B. Braun Medical is recalling 122,232 IV administration sets over the potential for medication backflow from secondary piggyback containers and an 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-0630-2026·2025-12-03
IV extension sets recalled over backflow between piggyback and primary containers
B. Braun Medical is recalling 43,452 extension sets over the potential for medication backflow from secondary piggyback containers and an 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 numbers: 1. EXTENSION SET, 18 IN; Catalog Numb
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0684-2026·2025-12-03
Anesthesia set 490472 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 10,536 units anesthesia iv sets over the potential for medication backflow from secondary piggyback containers and an 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 ADM 15D 2 CARESITE, SAFE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0604-2026·2025-12-03
ADDitIV sets recalled over backflow between primary and secondary containers
B. Braun Medical is recalling 100 ADDitIV administration sets over the potential for medication backflow from secondary piggyback containers and an 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. V1782F UNIV IV SET W/0.2 MICRON FILTER; C
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0708-2026·2025-12-03
Outlook pump sets recalled over backflow into the primary container
B. Braun Medical is recalling 2,352 Outlook pump sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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-0680-2026·2025-12-03
Gravity IV sets recalled over medication backflow and inability to prime
B. Braun Medical is recalling 12,200 IV administration sets over the potential for medication backflow from secondary piggyback containers and an 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. NF1503 15 DR UNIV SPIKE, IN
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0614-2026·2025-12-03
Anesthesia set 490468 recalled over backflow and inability to prime
B. Braun Medical is recalling 58,752 anesthesia IV sets over the potential for medication backflow from secondary piggyback containers and an 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-0606-2026·2025-12-03
Anesthesia set 490189 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 32,436 anesthesia IV sets over the potential for medication backflow from secondary piggyback containers and an 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, 108
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0626-2026·2025-12-03
Caresite set 354207 recalled over backflow and priming occlusion
B. Braun Medical is recalling 381,850 Caresite primary gravity sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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-0603-2026·2025-12-03
Primary gravity sets recalled over backflow from secondary containers
B. Braun Medical is recalling 43,900 ADDitIV primary gravity sets over the potential for medication backflow from secondary piggyback containers and an 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-0623-2026·2025-12-03
CARESAFE set 354302 recalled over backflow and inability to prime
B. Braun Medical is recalling 4,438 CARESAFE sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
CARESAFE 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. CARESAFE IV ADMIN SET w/AIRSTOP, 104 IN
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0655-2026·2025-12-03
IV set 457504 recalled over medication backflow and priming failure
B. Braun Medical is recalling 80,650 IV administration sets over the potential for medication backflow from secondary piggyback containers and an 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 SET W/2 CARESITE & 2 ULT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0717-2026·2025-12-03
IV set 490508 recalled over backflow into the primary container
B. Braun Medical is recalling IV administration set catalog number 490508 over the potential for medication backflow from secondary piggyback containers and an 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/ 15DROPS/ML;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0649-2026·2025-12-03
IV set 490208 recalled over medication backflow between IV containers
B. Braun Medical is recalling 40,008 IV administration sets over the potential for medication backflow from secondary piggyback containers and an 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 DR / mL W
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0625-2026·2025-12-03
Caresite set 354202 recalled over backflow and inability to prime
B. Braun Medical is recalling 2,871,707 units caresite sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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-0622-2026·2025-12-03
Burette set 490159 recalled over backflow into the primary container
B. Braun Medical is recalling 7,240 burette sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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-0691-2026·2025-12-03
IV set 490408 recalled over backflow between primary and secondary containers
B. Braun Medical is recalling 24,072 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an 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-0696-2026·2025-12-03
IV set 490437 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 4,536 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an 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-0611-2026·2025-12-03
Anesthesia infusion sets recalled over backflow into the primary bag
B. Braun Medical is recalling 19,392 anesthesia IV sets over the potential for medication backflow from secondary piggyback containers and an 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, 15 DROPS/ML 125 I
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0667-2026·2025-12-03
Infusion pump sets recalled over medication backflow and occlusion
B. Braun Medical is recalling 37,656 IV administration sets over the potential for medication backflow from secondary piggyback containers and an 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, 16
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0634-2026·2025-12-03
Extension sets recalled over piggyback backflow into primary containers
B. Braun Medical is recalling 23,650 extension sets over the potential for medication backflow from secondary piggyback containers and an 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. EXTENSION SET W/ ULTRAPORT, 48 IN.;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0677-2026·2025-12-03
IV set 490612 recalled over medication backflow between IV containers
B. Braun Medical is recalling 5,952 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an 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. 15DR 2SAFELINE 1CARESITE 1S
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0664-2026·2025-12-03
IV set 490315 recalled over backflow between primary and secondary containers
B. Braun Medical is recalling 11,832 IV administration sets over the potential for medication backflow from secondary piggyback containers and an 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, 15 DR/ML,2 CA
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0612-2026·2025-12-03
Anesthesia set 490444 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 88,200 anesthesia IV sets over the potential for medication backflow from secondary piggyback containers and an 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, 15D 2 CARESITE LA
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0671-2026·2025-12-03
Vented pump sets recalled over medication backflow and occlusion risk
B. Braun Medical is recalling 12,168 IV administration sets over the potential for medication backflow from secondary piggyback containers and an 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

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.