The Recall Desk

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.

126–150 of 447

  • 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.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0695-2026·2025-12-03

    IV set 490193 recalled over backflow and inability to prime

    B. Braun Medical is recalling 111,312 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 HF 4-WAY…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0713-2026·2025-12-03

    SAFELINE set 352604 recalled over backflow from secondary containers

    B. Braun Medical is recalling 46,250 SAFELINE sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    SAFELINE 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. UNIVERSAL IV ADMIN SET; Catalog…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0700-2026·2025-12-03

    IV set 490088 recalled over medication backflow and priming failure

    B. Braun Medical is recalling iv administration sets, catalog number 490088, 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. NF1505, IV ADMIN SET W/2…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0653-2026·2025-12-03

    IV set 490329 recalled over backflow and inability to prime

    B. Braun Medical is recalling 18,984 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, 81 IN W/ 32…
    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-0629-2026·2025-12-03

    Extension set 456520 recalled over backflow and priming occlusion

    B. Braun Medical is recalling 2,100 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. ANES SET W/DUAL FEM.LL SAFEPORT…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0609-2026·2025-12-03

    Anesthesia set 490477 recalled over backflow and inability to prime

    B. Braun Medical is recalling 36,552 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 W/15 DROPS/ML…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0683-2026·2025-12-03

    IV set 354211 recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 286,400 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 ADM 15 DROP W/3…
    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…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0617-2026·2025-12-03

    Blood set 490355 recalled over backflow into the primary container

    B. Braun Medical is recalling 24,624 units 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 W/ 170…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0660-2026·2025-12-03

    IV set 490343 recalled over piggyback backflow and priming occlusion

    B. Braun Medical is recalling 1,272 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 CARESITE…
    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…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0707-2026·2025-12-03

    Outlook set 354213 recalled over backflow into the primary container

    B. Braun Medical is recalling 18,072 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/3 CARESITE…
    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…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0662-2026·2025-12-03

    IV set 490367 recalled over medication backflow and priming failure

    B. Braun Medical is recalling 6,768 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/60 DR/ML…
    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…
    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…
    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
  • 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-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
  • 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…
    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-0123-2026·2025-10-15

    Open tip spinal epidural trays recalled over catheter connector lid position

    B. Braun is recalling 2,840 Combined Spinal and Epidural Anesthesia Trays, product code NES1727KFX, because the lid of the catheter connector may be in the incorrect position.

    Product
    Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle and 19 Ga. Open Tip PERIFIX FX Springwound Epidural Catheter. Product Code: NES1727KFX. Product Description: NES1727KFX W /17GA…
    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

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.