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.

126–150 of 446

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-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 Numb
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0650-2026·2025-12-03
IV set 490317 recalled over backflow and occlusion risk
B. Braun Medical is recalling 6,650 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 AD SET CARESITE 127 IN.
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, 124
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0619-2026·2025-12-03
Blood administration sets recalled over backflow and priming failure
B. Braun Medical is recalling 164,568 blood administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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, HAND P
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-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-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-0644-2026·2025-12-03
IV set 352394 recalled over backflow between primary and secondary containers
B. Braun Medical is recalling 1,250 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. US1295 ULTRASITE IV ADMIN S
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-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-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-0628-2026·2025-12-03
Smallbore extension sets recalled over backflow and inability to prime
B. Braun Medical is recalling 30,250 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. ET08US EXTENSION SET W/ULTRA Y SITE
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 DROPS/ML
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0712-2026·2025-12-03
SafeDAY set 352646 recalled over backflow and priming occlusion
B. Braun Medical is recalling 554,015 SafeDAY sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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
ModerateFDA (Devices)·Z-0656-2026·2025-12-03
Bronchoscopy robots recalled because the user manual was password protected
Noah Medical is recalling 47 Galaxy Systems because users did not have access to the Instructions for Use and User Manual, which was password protected.
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
ModerateFDA (Devices)·Z-0666-2026·2025-12-03
Liquid biopsy reports recalled for omitting the companion diagnostic claims page
Foundation Medicine is recalling 18 FoundationOne Liquid CDx reports that were sent to customers without the companion diagnostic Claims Page.
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
CriticalFDA (Devices)·Z-0070-2026·2025-10-29
Hemodialysis bloodline sets recalled over micro air bubbles from damaged connectors
B. Braun is recalling Streamline Bloodline Sets for Dialog because damaged arterial and venous patient connectors may cause micro-air bubbles in the bloodline and air-in-line alarms.
Product
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0117-2026·2025-10-15
Winged needle epidural trays recalled over catheter connector lid position
B. Braun is recalling PERIFIX FX Continuous Epidural Anesthesia Trays, product code CE17TKF, because the lid of the catheter connector may be in the incorrect position.
Product
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKF. Product Description: CE17TKF PERIFIX CONTIN. EPIDURAL TRAY
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0126-2026·2025-10-15
Custom epidural anesthesia trays recalled over catheter connector lid position
B. Braun is recalling 5,770 Design Options PERIFIX FX Epidural Anesthesia Trays because the lid of the catheter connector may be in the incorrect position.
Product
Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD JOHNSON UNIV HOSP. 2. CESK EAST JEFFERSON GEN HOSP 20071769. 3. CESK FLETCHER ALLEN HOSPITAL. 4. CESK WASHOE MEDICAL CENTER. 5. CESK DETROIT MEDI
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0116-2026·2025-10-15
Winged closed tip epidural trays recalled over catheter connector lid position
B. Braun is recalling 48,110 PERIFIX FX Continuous Epidural Anesthesia Trays, product code CE17TKFC, because the lid of the catheter connector may be in the incorrect position.
Product
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFC. Product Description: CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0124-2026·2025-10-15
Pain management trays recalled over catheter connector lid position defect
B. Braun is recalling 2,450 Design Options Pain Management Trays because the lid of the catheter connector may be in the incorrect position.
Product
Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWENSBORO DAVIESS HOSP 20058814. 3. SESK MEMORIAL HEALTH SYSTEM SPINAL/EPID. 4. SESK ST. JOHN'S MERCY MED CTR SPINAL/EPID. 5. SESK MAIMONI
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0118-2026·2025-10-15
Fixed wing epidural trays recalled over catheter connector lid position
B. Braun is recalling PERIFIX FX Continuous Epidural Anesthesia Trays, product code CE17TKFSDT, because the lid of the catheter connector may be in the incorrect position.
Product
PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Product Description: CE17TKFSDT EPID TRAY W/17GA FIXED WING.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0120-2026·2025-10-15
Open tip epidural trays recalled over catheter connector lid position
B. Braun is recalling 2,760 PERIFIX FX Continuous Epidural Anesthesia Trays, product code CE17TKFS, because the lid of the catheter connector may be in the incorrect position.
Product
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFS. Product Description: CE17TKFS EPIDURAL TRAY.
Category
Medical Device
Distribution
Distributed nationwide

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.