Manufacturer

B. Braun Medical, Inc.

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

What the numbers show

Total: 447
Critical: 10
Severe: 45
Most recent: 2026-09-16

Of the 447 recalls from B. Braun Medical, Inc. we have scored against our rubric, 10 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 45 (10%) 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.

101–125 of 447

HighFDA (Devices)·Z-0718-2026·2025-12-03
IV set 490566 recalled over backflow from secondary piggyback containers
B. Braun Medical is recalling iv administration set catalog number 490566 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, 110 IN.…
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…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0633-2026·2025-12-03
IV set 490283 recalled over backflow between primary and secondary containers
B. Braun Medical is recalling 65,904 units iv administration 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/ B/C VALVE 53 in.…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0681-2026·2025-12-03
IV set 490426 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 63,192 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/10 DROPS…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0658-2026·2025-12-03
IV set 470005 recalled over medication backflow and priming failure
B. Braun Medical is recalling 29,900 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 SET 15DR 3 CARESITE…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0642-2026·2025-12-03
IV set 490385 recalled over medication backflow between IV containers
B. Braun Medical is recalling 168,816 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 numbers: 1. IV ADMIN SET, 10…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0674-2026·2025-12-03
IV set 490507 recalled over backflow and inability to prime
B. Braun Medical is recalling 48,672 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 ADMINISTRATION SET WITH…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0670-2026·2025-12-03
IV set 352636 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 20,694,734 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 15 DR W/2…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0685-2026·2025-12-03
IV set 490312 recalled over medication backflow between IV containers
B. Braun Medical is recalling 226,632 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 ADMN SET W/15 DROP…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0639-2026·2025-12-03
Extension set V5405 recalled over backflow and inability to prime
B. Braun Medical is recalling 300 units 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. EXT/2INJ/FLBL/FML LRLK/CV 34…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0640-2026·2025-12-03
Universal infusion sets recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 49,330,370 Infusomat administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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-0661-2026·2025-12-03
IV set 490309 recalled over backflow into the primary bag
B. Braun Medical is recalling 259,392 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/ 2…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0703-2026·2025-12-03
IV set 490301 recalled over backflow from secondary piggyback containers
B. Braun Medical is recalling 31,392 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 AD.SET W/15 DR 128 IN…
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-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…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0631-2026·2025-12-03
Extension set 490629 recalled over backflow and priming occlusion
B. Braun Medical is recalling 13,128 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, 25 IN.; Catalog…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0643-2026·2025-12-03
IV set NF1270A recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 13,870 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. NF1270A SAFELINE…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0613-2026·2025-12-03
Anesthesia set 490476 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 19,320 units 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, 2-HIGH FLOW…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0709-2026·2025-12-03
Outlook set 354212 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 162,648 units outlook 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 IV SET 15DROP W/2 CARESITE…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0697-2026·2025-12-03
IV set 480231 recalled over backflow from secondary piggyback containers
B. Braun Medical is recalling 85,176 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…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0657-2026·2025-12-03
IV set 490427 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 224,856 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…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0668-2026·2025-12-03
IV set 490504 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 36,936 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…
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…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0673-2026·2025-12-03
IV set 490522 recalled over backflow from secondary piggyback containers
B. Braun Medical is recalling 41,016 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, 15DR…
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

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.